Apparatus, Suction, Operating-Room, Wall Vacuum Powered
FDA product code GCX · Class II (moderate risk) · 21 CFR 880.6740 · General Hospital
87510(k) clearances
0PMA approvals
35recalls
Manufacturers
- Westmark, Sterile Packing Systems, Inc. (Sps) 6
- Deknatel, Inc. 4
- Sherwood Medical Industries 3
- Sorensen Research 3
- Sherwood Medical Co. 3
- Stryker Endoscopy 3
- J. H. Emerson Co. 2
- Rico Suction Laboratories, Inc. 2
- Boehringer Laboratories 2
- Arbor Technologies, Inc. 2
- Howmedica Corp. 2
- Impact Instrumentation, Inc. 2
- C.R. Bard, Inc. 2
- Abbott Laboratories 2
- Ohio Medical Products 2
- Cox-Uphuff Intl. 1
- Imedix 1
- Circon Corp. 1
- Medline Industries, LP 1
- Farley, W.T. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042454 | Stryker Cassette PumpGCX · Traditional | Stryker Endoscopy | 12/09/2004SE |
| K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation SystemGCX · Traditional | Circon Corp. | 08/03/1999SE |
| K972074 | Suction InstrumentationGCX · Traditional | Walter Lorenz Surgical, Inc. | 07/25/1997SE |
| K971022 | Chase SuckerGCX · Traditional | Chase Medical, Inc. | 04/17/1997SE |
| K964127 | Medi-Vac Flexi-Clear Suction HandleGCX · Traditional | Allegiance Healthcare Corp. | 12/31/1996SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 12/20/1996SE |
| K963648 | Stryker Suction RegulatorGCX · Traditional | Stryker Endoscopy | 11/26/1996SE |
| K962920 | Renton Suction Device U.S. PATENT*4,767,404GCX · Traditional | R&S Surgical, LLC | 10/21/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | Medcare Medical Group, Inc. | 07/19/1996SE |
| K960223 | CPR YankauerGCX · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | Medcare Custom Packaging, Inc. | 01/19/1996SE |
| K954726 | Stryker Strykeflow Suction Irrigator (Modification)GCX · Traditional | Stryker Endoscopy | 11/29/1995SE |
| K952219 | Suction Tip Cleaner CupGCX · Traditional | Moore/Gobel | 11/15/1995SE |
| K951119 | Nezhat-Dorsey Specimen Container SystemGCX · Traditional | American Hydro-Surgical Instruments, Inc. | 06/13/1995SE |
| K950464 | Sscor/Board ..3 Model 23000 Pre-Assembled Suction System for Patient Transport VehiclesGCX · Traditional | Sscor | 04/25/1995SE |
| K931548 | Inamed Development Aspiration TipGCX · Traditional | Inamed Development Co. | 01/10/1994SE |
| K924570 | Oem Multi-Vac Powered Suction PumpGCX · Traditional | Oem Medical Div. | 08/05/1993SE |
| K920912 | The Medic TMGCX · Traditional | Medical and Environment Designs, Inc. | 07/30/1993SE |
| K924337 | Pleur-Evac(R) Adult/Pedi Dual Coll Chest Drain SysGCX · Traditional | Deknatel, Inc. | 07/28/1993SE |
| K924577 | MedivacGCX · Traditional | Medisonic U.S.A., Inc. | 03/23/1993SE |
| K911238 | Tahoe Suction IrrigatorGCX · Traditional | Tahoe Pro Instruments | 11/27/1992SE |
| K920248 | Model Slase 210 Holmium Laser SystemGCX · Traditional | Sunrise Technologies, Inc. | 07/21/1992SESK |
| K914601 | Suction Connecting TubingGCX · Traditional | Bemis Mfg. Co. | 02/07/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | Xomed-Treace, Inc. | 09/23/1991SE |
| K910377 | Coopersurgical Model 6080 Smoke Evacuator SystemGCX · Traditional | CooperSurgical, Inc. | 04/19/1991SE |
| K910218 | Laparomed Cholangiogram Vacuum DeviceGCX · Traditional | Laparomed Corp. | 04/08/1991SE |
| K905448 | Thora-Klex Chest Drainage UnitGCX · Traditional | Davol, Inc. | 03/27/1991SE |
| K895859 | Contain(Tm)GCX · Traditional | Arbor Technologies, Inc. | 02/07/1991SE |
| K896134 | Acuflo, Vacuum-Powered Body Fluid Suction Appara.GCX · Traditional | Goosen Enterprises, Inc. | 08/30/1990SE |
| K901937 | Codman Suction PattieGCX · Traditional | Codman & Shurtleff, Inc. | 07/16/1990SE |
| K902089 | Equi-Guard (Aspirator Filter)GCX · Traditional | Equi-Tron Mfg., Inc. | 07/06/1990SE |
| K896804 | ManifoldGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/06/1990SE |
| K896562 | StopcockGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/06/1990SE |
| K896558 | Yankauer Suction Tube-Rigid TypeGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/06/1990SE |
| K896557 | Yankauer Suction Tube-Flexible TypeGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/06/1990SE |
| K896556 | Universal Poole Suction TubeGCX · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 02/06/1990SE |
| K894695 | Vacusafe Disp. Vacuum - Extraction SystemGCX · Traditional | Medistad Corp. | 01/22/1990SE |
| K895039 | Sterile Saline - for Suction Catheter LubricationGCX · Traditional | Aplicare, Inc. | 10/03/1989SE |
| K893649 | Meconium AspiratorGCX · Traditional | Gish Biomedical, Inc. | 08/21/1989SE |
| K893741 | Receptal (R) Saf-Gard(Tm) Suction LinerGCX · Traditional | Abbott Laboratories | 08/17/1989SE |
| K892549 | Suction Tubes: House, BaronGCX · Traditional | Zinnanti Surgical Instruments, Inc. | 05/18/1989SE |
| K890129 | Pleur-Evac(R) A-8020--INFANT Chest Drainage SystemGCX · Traditional | Deknatel, Inc. | 04/10/1989SE |
| K890431 | Pleur-Evac(R) A-8000--ADULT/PEDIATRIC Chest DrainGCX · Traditional | Deknatel, Inc. | 04/04/1989SE |
| K885208 | Receptal Saf-Gard(Tm) SystemGCX · Traditional | Abbott Laboratories | 03/17/1989SESD |
| K885334 | Vac-RiteGCX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/08/1989SE |
| K884103 | Remote Vacuum Booster System, 7600 SeriesGCX · Traditional | Boehringer Laboratories | 03/03/1989SE |
| K881252 | Pleur-Evac(R) A6000 Adult/Pediatric Chest DrainageGCX · Traditional | Deknatel, Inc. | 06/17/1988SE |
| K874505 | Contain(Tm)GCX · Traditional | Arbor Technologies, Inc. | 05/20/1988SE |
| K870874 | Cspi Specimen Trap (Non-Sterile)GCX · Traditional | Custom Surgical Products, Inc. | 04/19/1988SE |
| K880704 | Cerullo Suction RegulatorGCX · Traditional | Aesculap Instruments Corp. | 03/29/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | J. H. Emerson Co. | 12/29/1987SE |
| K861261 | Ohmeda Posi-Pulse Suction UnitGCX · Traditional | Ohmeda Medical | 05/30/1986SE |
| K853095 | Boehringer Laboratories Suction IntermittorGCX · Traditional | Boehringer Laboratories | 08/23/1985SE |
| K851384 | Medical/Surgical Suction SystemGCX · Traditional | Puritan Bennett Corp. | 05/08/1985SE |
| K844882 | Rico RS-6X Emergency Medical AspiratorGCX · Traditional | Rico Suction Laboratories, Inc. | 03/01/1985SE |
| K844881 | Rico RS4-XP Emergency Medical AspiratorGCX · Traditional | Rico Suction Laboratories, Inc. | 03/01/1985SE |
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | Sorensen Research | 01/25/1984SE |
| K833673 | Accurate Measurement Device Ez-AmdGCX · Traditional | Sorensen Research | 12/29/1983SE |
| K831116 | Invac W/Various ModelsGCX · Traditional | Pmt | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | Sorensen Research | 07/19/1983SE |
| K823037 | Pleur-Evac A-4005 SystemGCX · Traditional | Howmedica Corp. | 10/28/1982SE |
| K822311 | Disposable Collection Bottle W/TubingGCX · Traditional | Ohio Medical Products | 08/20/1982SE |
| K822005 | Specimen CollectorsGCX · Traditional | Kelleher Corp. | 07/28/1982SE |
| K821841 | Medigas Suction/Drainage EquipmentGCX · Traditional | Linde Div. Union Carbide Corp. | 07/02/1982SE |
| K821160 | Pneumo Drain T.M. Recorder #PD-800GCX · Traditional | Sugen Industries, Inc. | 05/27/1982SE |
| K821023 | Thoracic Drainage SystemGCX · Traditional | Howmedica Corp. | 05/21/1982SE |
| K820765 | Pleural Drainage ReservoirGCX · Traditional | Innovative Surgical Products, Inc. | 04/15/1982SE |
| K820424 | Impact, Model 310GCX · Traditional | Impact Instrumentation, Inc. | 03/12/1982SE |
| K820337 | Impact, Model 303GCX · Traditional | Impact Instrumentation, Inc. | 03/02/1982SE |
| K813394 | DS-7 Closed Wound Suction Drain SystemGCX · Traditional | Cox-Uphuff Intl. | 01/22/1982SE |
| K813319 | Aspirator Venturi System Model 55-JVGCX · Traditional | J. H. Emerson Co. | 12/14/1981SE |
| K813029 | Valved Surgical AspiratorsGCX · Traditional | Imedix | 12/14/1981SE |
| K813066 | Argyle Yankauer Suction TubeGCX · Traditional | Sherwood Medical Co. | 11/16/1981SE |
| K812845 | Surgical Suction Instruments-Dispos.GCX · Traditional | Abco Dealers, Inc. | 11/16/1981SE |
| K802440 | Argyle Compact Chest Drainage Sys.GCX · Traditional | Sherwood Medical Co. | 10/23/1980SE |
| K801979 | Argyle Compact Chest Drainage SystemGCX · Traditional | Sherwood Medical Co. | 09/16/1980SE |
| K801942 | Ohio Thoracic Collection UnitGCX · Traditional | Ohio Medical Products | 09/16/1980SE |
| K790055 | Tubing, Dynacor UniversalGCX · Traditional | Medline Industries, Inc. | 02/22/1979SE |
| K781988 | Suction Apparatus, Powered by Comp. AirGCX · Traditional | Farley, W.T. | 12/12/1978SE |
| K771737 | Suction CanisterGCX · Traditional | Bemis Health Care | 12/20/1977SE |
| K760814 | Heparinized Penrose TubingGCX · Traditional | Sherwood Medical Industries | 11/03/1976SE |
| K760813 | Heparinized Saratoga Sump DrainGCX · Traditional | Sherwood Medical Industries | 11/03/1976SE |
| K760812 | Heparinized Wound Suction TubingGCX · Traditional | Sherwood Medical Industries | 11/03/1976SE |
| K760333 | Jar, Collector for Suction SystemsGCX · Traditional | Harris-Lake, Inc. | 10/27/1976SE |
| K760217 | Suction Instrument, Macbick Dis. Fraz.GCX · Traditional | C.R. Bard, Inc. | 08/23/1976SE |
| K760216 | Suction Instrument, Macbick Poole TipGCX · Traditional | C.R. Bard, Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2864-2026 Class II | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2863-2026 Class II | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2862-2026 Class II | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-1203-2026 Class II | Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal…The firm is updating the IFU to clarify the intended patient population for the identified chest drainage… | Cardinal Health 200, LLC | 12/26/2025Open, Classified |
| Z-2171-2025 Class II | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery… | Stryker Corporation | 06/18/2025Open, Classified |
| Z-0796-2025 Class II | SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm)…Incomplete or partial pouch seals, which may result in a breach in the sterility. | Med Michigan Holding Llc | 11/19/2024Open, Classified |
| Z-0756-2024 Class II | Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit…The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of… | Cardinal Health 200, LLC | 12/21/2023Open, Classified |
| Z-0755-2024 Class II | Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit…The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of… | Cardinal Health 200, LLC | 12/21/2023Open, Classified |
| Z-0754-2024 Class II | CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of… | Cardinal Health 200, LLC | 12/21/2023Open, Classified |
| Z-1955-2021 Class II | Synaptive Trackable Suction Set Standard and MalleableDue to visible burrs/metal filings affixed along the suction tube inner perimeter. | Synaptive Medical Inc | 04/23/2021Terminated |
| Z-1546-2018 Class II | Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF…products may be missing a one-way valve on the fluid patient port. | Cardinal Health 200, LLC | 03/28/2018Terminated |
| Z-0836-2018 Class II | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a.…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | Stryker Corporation | 11/17/2017Terminated |
| Z-2594-2016 Class II | Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01…Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal… | Hospira Inc. | 09/10/2013Terminated |
| Z-2593-2016 Class II | Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000…Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal… | Hospira Inc. | 09/10/2013Terminated |
| Z-0457-2014 Class II | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE…Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be… | Hospira Inc. | 07/17/2013Terminated |
| Z-1237-2013 Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1236-2013 Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1235-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1234-2013 Class II | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1233-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1232-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1231-2013 Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1230-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1229-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1228-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1227-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1226-2013 Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1225-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1224-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1223-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1222-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1221-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish.…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1220-2013 Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1219-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |
| Z-1218-2013 Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction…The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly… | Stryker Endoscopy | 03/27/2013Terminated |