FDA Product Code
FDA Product Code LDR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | 2024-10-07 | Special | PDF ↗ |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024-03-01 | Traditional | PDF ↗ |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | 2016-10-03 | Traditional | PDF ↗ |
| K963136 | PACER MODEL 100 INFUSION CONTROLLER | Health Watch, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | Alexander Mfg. Co. | 1997-07-03 | Traditional | PDF ↗ |
| K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | Alexander Mfg. Co. | 1997-07-03 | Traditional | PDF ↗ |
| K934543 | UNIVERSAL CONTROLLER, MODEL 100 | Metamed, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K935236 | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K905498 | STAT 2 IV PUMPETTE | The Master Medical Corp. | 1991-04-16 | Traditional | PDF ↗ |
| K905497 | MASTER FLOW I.V. PUMPETTE | The Master Medical Corp. | 1991-04-16 | Traditional | PDF ↗ |
| K896907 | 3M IV FLOW REGULATOR | 3M Company | 1990-02-26 | Traditional | PDF ↗ |
| K894111 | VARI-SET | Sonex Medical | 1989-09-28 | Traditional | PDF ↗ |
| K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | 1989-09-27 | Traditional | PDF ↗ |
| K893487 | LIFECARE 75 CONTROLLER | Abbott Laboratories | 1989-07-28 | Traditional | PDF ↗ |
| K884307 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | Y | 1988-11-01 | Traditional | PDF ↗ |
| K882167 | IVY COMMANDER, MODEL 600 | Ivy Medical, Inc. | 1988-09-23 | Traditional | PDF ↗ |
| K880006 | STA-SET I.V. FLOW REGULATOR | Controlled Flow , Ltd. | 1988-03-24 | Traditional | PDF ↗ |
| K874916 | TECHNICON CHEM 1(TM) SYSTEM | Technicon Instruments Corp. | 1988-03-03 | Traditional | PDF ↗ |
| K874481 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | Y | 1988-03-03 | Traditional | PDF ↗ |
| K874491 | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | Y | 1988-02-25 | Traditional | PDF ↗ |
| K870820 | IVY COMMANDER (MODEL 500) | Ivy Medical, Inc. | 1988-01-20 | Traditional | PDF ↗ |
| K870317 | IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 | Y | 1987-04-03 | Traditional | PDF ↗ |
| K870132 | IVAC FLOW CONTROL ADMINISTRATION SET | Y | 1987-02-05 | Traditional | PDF ↗ |
| K864789 | BETAFLO 2000 PIGGYBACK SYSTEM | Betaflo, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K864229 | STA-SET MODEL 250 I.V. FLOW REGULATOR | Sta-Set Corp. | 1986-12-16 | Traditional | PDF ↗ |
| K863204 | DEKA JR. | Deka Research & Development Corp. | 1986-09-03 | Traditional | PDF ↗ |
| K862273 | BETAFLO 2000 | Betaflo, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K854863 | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER | Travenol Laboratories, S.A. | 1986-02-12 | Traditional | PDF ↗ |
| K855000 | RATEMINDER III INFUSION DEVICE | American Edwards Laboratories | 1986-02-12 | Traditional | PDF ↗ |
| K851058 | DOSI FLOW | Leventon, S.A. | 1985-04-29 | Traditional | PDF ↗ |
| K842209 | ARM-A-FLOW INTRAVENOUS FLOW REGULATOR | Armour Pharmaceutical Co. | 1984-12-04 | Traditional | PDF ↗ |
| K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER | Deka Research & Development Corp. | 1984-10-11 | Traditional | PDF ↗ |
| K842419 | IVAC 280 VOLUMETRIC INFUSION CONTROLLER | Y | 1984-08-07 | Traditional | PDF ↗ |
| K842210 | IVENT 302VC DUAL CONTROLLER | Ivent Corp. | 1984-07-25 | Traditional | PDF ↗ |
| K841318 | A.S.A.P. | Trimedyne, Inc. | 1984-07-18 | Traditional | PDF ↗ |
| K842080 | ABBOTT LIFECARE 1050 CONTROLLER | Abbott Laboratories | 1984-07-18 | Traditional | PDF ↗ |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | Cutter Laboratories, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K840942 | IVY COMMANDEER | Ivy Medical, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K840823 | TREONIC C30 | Vickers America Medical Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K840644 | FLO-GARD 4000 VOLUMETRIC INFUSION | Travenol Laboratories, S.A. | 1984-03-23 | Traditional | PDF ↗ |
| K834528 | MODEL 2001 INTELLIGENT INFUSOR | Quest Medical, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K834154 | FLO-GARD 8000 COMPUTER CONTROL INFUSI | Travenol Laboratories, S.A. | 1984-01-25 | Traditional | PDF ↗ |
| K833953 | ELECTRONIC GRAVITY 300VC | Ivent Corp. | 1983-12-29 | Traditional | PDF ↗ |
| K832739 | STEDIFLO INFUSION SET | Dravon Medical, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K833520 | RATEMINDER II SPECIALTY CARE | Anatros Corp. | 1983-12-22 | Traditional | PDF ↗ |
| K833682 | PRIMARY PIGGYBACK INFUSION SET W/PERM | Cosmetic Sciences, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K832702 | POCKET AID | M.C. Johnson Co., Inc. | 1983-11-17 | Traditional | PDF ↗ |
| K830780 | KOALA C99 I.V. CONTROLLER | Chesebrough-Pond'S U.S.A. Co. | 1983-04-08 | Traditional | PDF ↗ |
| K823404 | VOLUMERIC CONTROLLER | Quest Medical, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K822891 | FLO CONTROL | Dna Medical, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K823026 | 380 PIGGYBACK CONTROLLER | Imed Corp. | 1982-11-22 | Traditional | PDF ↗ |
| K822603 | PERMA-SET INFUSION SET | Cosmetic Sciences, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K821579 | SKIN SCRUB-TRAY | Associated Medical Products Co. | 1982-07-21 | Traditional | PDF ↗ |
| K812510 | TRAVENOL INFUSION CONTROLLER 2M8052 | Travenol Laboratories, S.A. | 1981-09-16 | Traditional | PDF ↗ |
| K812233 | RATEMINDER | Anatros Corp. | 1981-08-25 | Traditional | PDF ↗ |
| K812114 | LIFECARE 1000 CONTROLLER | Abbott Laboratories | 1981-08-20 | Traditional | PDF ↗ |
| K811432 | MILLIPORE DUAL RATE INTRAVENOUS CASSETTE | Millipore Corp. | 1981-07-13 | Traditional | PDF ↗ |
| K801861 | IVAC 260 SERIES VOLUME TRIC INFUSION CON | Y | 1980-08-27 | Traditional | PDF ↗ |
| K771158 | ID BRACLETS, ADULT & INFANT | Divers-A-Med | 1977-10-13 | Traditional | PDF ↗ |
| K760491 | TUMBLER, GENERAL MEDICAL MEDI-PAK | Landmark Plastics | 1976-09-15 | Traditional | PDF ↗ |
Product code LDR · Class II · General Hospital. Data: openFDA.