Controller, Infusion, Intravascular, Electronic
FDA product code LDR · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital
60510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Y 8
- Travenol Laboratories, S.A. 4
- Deka Research & Development Corp. 3
- Abbott Laboratories 3
- Ivy Medical, Inc. 3
- Deka Research and Development 2
- Betaflo, Inc. 2
- The Master Medical Corp. 2
- Ivent Corp. 2
- Alexander Mfg. Co. 2
- Quest Medical, Inc. 2
- Cosmetic Sciences, Inc. 2
- Anatros Corp. 2
- Dna Medical, Inc. 1
- Chesebrough-Pond'S U.S.A. Co. 1
- M.C. Johnson Co., Inc. 1
- Imed Corp. 1
- Vickers America Medical Corp. 1
- Associated Medical Products Co. 1
- Millipore Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | Deka Research and Development Corporation | 10/07/2024SE |
| K232316 | DEKA Infusion System, DEKA Administration SetLDR · Traditional | Deka Research and Development | 03/01/2024SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | DEKA Research & Development | 10/03/2016SE |
| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K905497 | Master Flow I.V. PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K896907 | 3M IV Flow RegulatorLDR · Traditional | 3M Company | 02/26/1990SE |
| K894111 | Vari-SetLDR · Traditional | Sonex Medical | 09/28/1989SE |
| K894487 | Ivac(R) Volumetric Controller - Model 262+LDR · Traditional | Y | 09/27/1989SE |
| K893487 | Lifecare 75 ControllerLDR · Traditional | Abbott Laboratories | 07/28/1989SE |
| K884307 | Ivac(R) Volumetric Controller - Model 262LDR · Traditional | Y | 11/01/1988SE |
| K882167 | Ivy Commander, Model 600LDR · Traditional | Ivy Medical, Inc. | 09/23/1988SE |
| K880006 | Sta-Set I.V. Flow RegulatorLDR · Traditional | Controlled Flow , Ltd. | 03/24/1988SE |
| K874916 | Technicon Chem 1(TM) SystemLDR · Traditional | Technicon Instruments Corp. | 03/03/1988SE |
| K874481 | Ivac(R) Volumetric Controller - Model 290LDR · Traditional | Y | 03/03/1988SE |
| K874491 | Ivac(R) Site-Saver(R) Volumetric Controller - 280+LDR · Traditional | Y | 02/25/1988SE |
| K870820 | Ivy Commander (Model 500)LDR · Traditional | Ivy Medical, Inc. | 01/20/1988SE |
| K870317 | Ivac (R) Site-Saver (TM) Volumetric Controller 280LDR · Traditional | Y | 04/03/1987SE |
| K870132 | Ivac Flow Control Administration SetLDR · Traditional | Y | 02/05/1987SE |
| K864789 | Betaflo 2000 Piggyback SystemLDR · Traditional | Betaflo, Inc. | 02/04/1987SE |
| K864229 | Sta-Set Model 250 I.V. Flow RegulatorLDR · Traditional | Sta-Set Corp. | 12/16/1986SE |
| K863204 | Deka Jr.LDR · Traditional | Deka Research & Development Corp. | 09/03/1986SE |
| K862273 | Betaflo 2000LDR · Traditional | Betaflo, Inc. | 07/18/1986SE |
| K855000 | Rateminder III Infusion DeviceLDR · Traditional | American Edwards Laboratories | 02/12/1986SE |
| K854863 | Flo-Gard 4000 Volumetric Infusion ControllerLDR · Traditional | Travenol Laboratories, S.A. | 02/12/1986SE |
| K851058 | Dosi FlowLDR · Traditional | Leventon, S.A. | 04/29/1985SE |
| K842209 | Arm-A-Flow Intravenous Flow RegulatorLDR · Traditional | Armour Pharmaceutical Co. | 12/04/1984SE |
| K843254 | DK*300 Volumetric Infusion ControllerLDR · Traditional | Deka Research & Development Corp. | 10/11/1984SE |
| K842419 | Ivac 280 Volumetric Infusion ControllerLDR · Traditional | Y | 08/07/1984SE |
| K842210 | Ivent 302VC Dual ControllerLDR · Traditional | Ivent Corp. | 07/25/1984SE |
| K842080 | Abbott Lifecare 1050 ControllerLDR · Traditional | Abbott Laboratories | 07/18/1984SE |
| K841318 | A.S.A.P.LDR · Traditional | Trimedyne, Inc. | 07/18/1984SE |
| K834106 | Intravenous Infusion ControllerLDR · Traditional | Cutter Laboratories, Inc. | 05/30/1984SE |
| K840942 | Ivy CommandeerLDR · Traditional | Ivy Medical, Inc. | 03/30/1984SE |
| K840823 | Treonic C30LDR · Traditional | Vickers America Medical Corp. | 03/23/1984SE |
| K840644 | Flo-Gard 4000 Volumetric InfusionLDR · Traditional | Travenol Laboratories, S.A. | 03/23/1984SE |
| K834528 | Model 2001 Intelligent InfusorLDR · Traditional | Quest Medical, Inc. | 02/21/1984SE |
| K834154 | Flo-Gard 8000 Computer Control InfusiLDR · Traditional | Travenol Laboratories, S.A. | 01/25/1984SE |
| K833953 | Electronic Gravity 300VCLDR · Traditional | Ivent Corp. | 12/29/1983SE |
| K833520 | Rateminder II Specialty CareLDR · Traditional | Anatros Corp. | 12/22/1983SE |
| K832739 | Stediflo Infusion SetLDR · Traditional | Dravon Medical, Inc. | 12/22/1983SE |
| K833682 | Primary Piggyback Infusion Set W/PermLDR · Traditional | Cosmetic Sciences, Inc. | 11/28/1983SE |
| K832702 | Pocket AidLDR · Traditional | M.C. Johnson Co., Inc. | 11/17/1983SE |
| K830780 | Koala C99 I.V. ControllerLDR · Traditional | Chesebrough-Pond'S U.S.A. Co. | 04/08/1983SE |
| K823404 | Volumeric ControllerLDR · Traditional | Quest Medical, Inc. | 12/22/1982SE |
| K822891 | Flo ControlLDR · Traditional | Dna Medical, Inc. | 11/24/1982SE |
| K823026 | 380 Piggyback ControllerLDR · Traditional | Imed Corp. | 11/22/1982SE |
| K822603 | Perma-Set Infusion SetLDR · Traditional | Cosmetic Sciences, Inc. | 09/14/1982SE |
| K821579 | Skin Scrub-TrayLDR · Traditional | Associated Medical Products Co. | 07/21/1982SE |
| K812510 | Travenol Infusion Controller 2M8052LDR · Traditional | Travenol Laboratories, S.A. | 09/16/1981SE |
| K812233 | RateminderLDR · Traditional | Anatros Corp. | 08/25/1981SE |
| K812114 | Lifecare 1000 ControllerLDR · Traditional | Abbott Laboratories | 08/20/1981SE |
| K811432 | Millipore Dual Rate Intravenous CassetteLDR · Traditional | Millipore Corp. | 07/13/1981SE |
| K801861 | Ivac 260 Series Volume Tric Infusion ConLDR · Traditional | Y | 08/27/1980SE |
| K771158 | Id Braclets, Adult & InfantLDR · Traditional | Divers-A-Med | 10/13/1977SE |
| K760491 | Tumbler, General Medical Medi-PakLDR · Traditional | Landmark Plastics | 09/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0804-2018 Class II | STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets…Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | ConMed Corporation | 06/19/2017Terminated |
| Z-0683-2012 | STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length…ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the… | ConMed Corporation | 04/15/2011Terminated |
| Z-0682-2012 | STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO…ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the… | ConMed Corporation | 04/15/2011Terminated |
| Z-0629-2012 | STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525…ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined… | ConMed Corporation | 04/15/2011Terminated |
| Z-2601-2011 | "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA…Leventon, S.A.U. Barcelona, Spain is recalling DOSI-FLOW REGULATOR, Part Number 259-0250, Lot Numbers… | Leventon S. A. U. | 03/11/2011Terminated |