Stand, Infusion
FDA product code FOX · Class I (low risk) · 21 CFR 880.6990 · General Hospital
36510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Ferguson Medical 3
- E.F. Brewer Co. 2
- Intl. Medication Systems, Ltd. 1
- Clinton Industries, Inc. 1
- Arthro-Medic, Inc. 1
- Rbd Medical, Inc. 1
- Dittmar and Penn Corp. 1
- Cambridge Technologies, Inc. 1
- Camtec 1
- I.V. League Medical 1
- Demstar Corp. 1
- Poly Medical Technologies, Inc. 1
- Terumo America, Inc. 1
- Gray Wave Corp. 1
- Northern Customfab, Inc. 1
- Broadwest Corp. 1
- Scholten Surgical Instruments, Inc. 1
- Kareco Intl., Inc. 1
- Impact Instrumentation, Inc. 1
- Manuco Manufacturing Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980336 | IV StandsFOX · Traditional | Clinton Industries, Inc. | 04/06/1998SE |
| K964782 | Medrad Contrast HolderFOX · Traditional | Medrad, Inc. | 02/25/1997SE |
| K961470 | Port-A-PoleFOX · Traditional | Prins Medical Ind., Inc. | 07/22/1996SE |
| K960027 | High Volume I.V. & Irrigation TowerFOX · Traditional | Allen Medical Systems, Inc. | 03/12/1996SE |
| K952196 | IV Pole/StandFOX · Traditional | Valentine Intl. , Ltd. | 07/31/1995SE |
| K950367 | IV ShuttleFOX · Traditional | Equipment Concepts, Inc. | 04/26/1995SE |
| K946201 | Stand, InfusionFOX · Traditional | Medical Specialties, Inc. | 04/18/1995SE |
| K944580 | Flexsys Mobilemate Equipment StandFOX · Traditional | Hill-Rom, Inc. | 03/17/1995SE |
| K932498 | Mobile Care IV StandFOX · Traditional | Mobile Care, Inc. | 10/27/1993SE |
| K925066 | Pneumatic Irrigation StandardFOX · Traditional | Arthrodyn, Inc. | 07/28/1993SE |
| K912010 | I.V. Sky-HookFOX · Traditional | Dina - Industria, Comercio E Exportacao , Ltd. | 08/19/1991SE |
| K900981 | Intravenous Stand or IV StandFOX · Traditional | Travl-Med Infusion Device Transport System | 03/27/1990SE |
| K895776 | Aiv Systems' IV PolesFOX · Traditional | Automated IV Systems, Inc. | 02/28/1990SE |
| K893597 | Hydraulic IV PoleFOX · Traditional | Arthro-Medic, Inc. | 10/10/1989SE |
| K883133 | Hanger, Intravenous/I.V. Bag Hanger or HolderFOX · Traditional | Ferguson Medical | 11/21/1988SE |
| K884341 | Critical Care I.V. Stand Stabilizing BracketFOX · Traditional | Rbd Medical, Inc. | 11/07/1988SE |
| K883260 | Dittmar Power LifterFOX · Traditional | Dittmar and Penn Corp. | 11/07/1988SE |
| K882493 | Rod, Irrigator Supporting, Telescoping TypeFOX · Traditional | Cambridge Technologies, Inc. | 07/19/1988SE |
| K880537 | Pole, IntravenousFOX · Traditional | Ferguson Medical | 04/06/1988SE |
| K880538 | Track and Carrier, IntravenousFOX · Traditional | Ferguson Medical | 02/19/1988SE |
| K872729 | Infusion StandFOX · Traditional | Camtec | 07/23/1987SE |
| K870473 | Stat-Stand(Tm) and Stat-Stand Ii(Tm)FOX · Traditional | I.V. League Medical | 02/13/1987SE |
| K864753 | Free Spirit(Tm) I.V. StandFOX · Traditional | Demstar Corp. | 01/20/1987SE |
| K861838 | PolypoleFOX · Traditional | Poly Medical Technologies, Inc. | 06/09/1986SE |
| K860468 | Unicaddy I & II I.V. Container Caddy Ims Pole MateFOX · Traditional | Intl. Medication Systems, Ltd. | 03/18/1986SE |
| K854082 | Porta-Pole TM Medical Equipment Pole W/FoldFOX · Traditional | Gray Wave Corp. | 11/01/1985SE |
| K852937 | The Ivy Pole-Intravenous Bot Trees #1121K & 1221KFOX · Traditional | Northern Customfab, Inc. | 07/26/1985SE |
| K852300 | Inox IV StandFOX · Traditional | Broadwest Corp. | 06/20/1985SE |
| K852329 | Stand, Operating RoomFOX · Traditional | Scholten Surgical Instruments, Inc. | 06/14/1985SE |
| K845031 | Kareco Int'L - Dougle-Hook I.V. StandFOX · Traditional | Kareco Intl., Inc. | 03/12/1985SE |
| K850671 | Impact 901 Series Port-A-WallFOX · Traditional | Impact Instrumentation, Inc. | 03/11/1985SE |
| K850245 | Brewer Heave-Duty I.V. Stand W/Foot Operated PnuemFOX · Traditional | E.F. Brewer Co. | 02/07/1985SE |
| K823270 | Heavy-Duty I.V. StandFOX · Traditional | E.F. Brewer Co. | 11/17/1982SE |
| K821405 | Magun Base I.V. PoleFOX · Traditional | Manuco Manufacturing Co., Inc. | 06/16/1982SE |
| K820963 | Patient Pal I.V. WalkerFOX · Traditional | Pryor Products | 04/21/1982SE |
| K770422 | Catheter, Surflo, I.V.FOX · Traditional | Terumo America, Inc. | 03/16/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1181-2018 Class II | Rotating IV Pole Rotating IV Pole falls under the category classified as capital…There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander… | Ohmeda Medical | 12/01/2017Terminated |
| Z-3239-2017 Class II | IVEA Product Part Number 16100 Model 500AThe dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate… | Firefly Medical, Inc. | 08/24/2017Terminated |
| Z-0767-2017 Class II | IVEA 500A Intended for Med-Surg patient care.The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to… | Firefly Medical, Inc. | 11/01/2016Terminated |
| Z-2890-2016 Class II | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion…Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the… | EKOS Corporation | 08/22/2016Terminated |
| Z-0344-2016 Class II | Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or…It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended… | Stryker Medical Division of Stryker… | 10/13/2015Terminated |