Panels › General Hospital › Product code LDR · Class 2
Controller, Infusion, Intravascular, Electronic
Regulation 880.5725
0510(k)s in 12 months (60 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in LDR
| Company | 510(k)s | Recalls |
|---|---|---|
| Y | 8 | 0 |
| ConMed Corporation | 0 | 4 |
| Travenol Laboratories, S.A. | 4 | 0 |
| Abbott Laboratories | 3 | 0 |
| DEKA Research & Development | 3 | 0 |
| Ivy Medical, Inc. | 3 | 0 |
| Alexander Mfg. Co. | 2 | 0 |
| Anatros Corp. | 2 | 0 |
| Betaflo, Inc. | 2 | 0 |
| Cosmetic Sciences, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2024 | K242693 | DEKA Infusion System, DEKA Administration Set Deka Research and Development Corporation | LDR |
| Mar 1, 2024 | K232316 | DEKA Infusion System, DEKA Administration Set Deka Research and Development | LDR |
| Oct 3, 2016 | K153760 | Volumetric Infusion Controller DEKA Research & Development | LDR |
| Oct 10, 1997 | K963136 | PACER MODEL 100 INFUSION CONTROLLER Health Watch, Inc. | LDR |
| Jul 3, 1997 | K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P Alexander Mfg. Co. | LDR |
| Jul 3, 1997 | K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 Alexander Mfg. Co. | LDR |
| Mar 29, 1994 | K934543 | UNIVERSAL CONTROLLER, MODEL 100 Metamed, Inc. | LDR |
| Feb 24, 1994 | K935236 | FLOW CONTROLLING EXTENSION SET Block Medical, Inc. | LDR |
| Apr 16, 1991 | K905498 | STAT 2 IV PUMPETTE The Master Medical Corp. | LDR |
| Apr 16, 1991 | K905497 | MASTER FLOW I.V. PUMPETTE The Master Medical Corp. | LDR |
| Feb 26, 1990 | K896907 | 3M IV FLOW REGULATOR 3M Company | LDR |
| Sep 28, 1989 | K894111 | VARI-SET Sonex Medical | LDR |
| Sep 27, 1989 | K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ Y | LDR |
| Jul 28, 1989 | K893487 | LIFECARE 75 CONTROLLER Abbott Laboratories | LDR |
| Nov 1, 1988 | K884307 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 Y | LDR |
| Sep 23, 1988 | K882167 | IVY COMMANDER, MODEL 600 Ivy Medical, Inc. | LDR |
| Mar 24, 1988 | K880006 | STA-SET I.V. FLOW REGULATOR Controlled Flow , Ltd. | LDR |
| Mar 3, 1988 | K874916 | TECHNICON CHEM 1(TM) SYSTEM Technicon Instruments Corp. | LDR |
| Mar 3, 1988 | K874481 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 Y | LDR |
| Feb 25, 1988 | K874491 | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ Y | LDR |
| Jan 20, 1988 | K870820 | IVY COMMANDER (MODEL 500) Ivy Medical, Inc. | LDR |
| Apr 3, 1987 | K870317 | IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 Y | LDR |
| Feb 5, 1987 | K870132 | IVAC FLOW CONTROL ADMINISTRATION SET Y | LDR |
| Feb 4, 1987 | K864789 | BETAFLO 2000 PIGGYBACK SYSTEM Betaflo, Inc. | LDR |
| Dec 16, 1986 | K864229 | STA-SET MODEL 250 I.V. FLOW REGULATOR Sta-Set Corp. | LDR |
| Sep 3, 1986 | K863204 | DEKA JR. Deka Research & Development Corp. | LDR |
| Jul 18, 1986 | K862273 | BETAFLO 2000 Betaflo, Inc. | LDR |
| Feb 12, 1986 | K855000 | RATEMINDER III INFUSION DEVICE American Edwards Laboratories | LDR |
| Feb 12, 1986 | K854863 | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER Travenol Laboratories, S.A. | LDR |
| Apr 29, 1985 | K851058 | DOSI FLOW Leventon, S.A., ES | LDR |
| Dec 4, 1984 | K842209 | ARM-A-FLOW INTRAVENOUS FLOW REGULATOR Armour Pharmaceutical Co. | LDR |
| Oct 11, 1984 | K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER Deka Research & Development Corp. | LDR |
| Aug 7, 1984 | K842419 | IVAC 280 VOLUMETRIC INFUSION CONTROLLER Y | LDR |
| Jul 25, 1984 | K842210 | IVENT 302VC DUAL CONTROLLER Ivent Corp. | LDR |
| Jul 18, 1984 | K842080 | ABBOTT LIFECARE 1050 CONTROLLER Abbott Laboratories | LDR |
| Jul 18, 1984 | K841318 | A.S.A.P. Trimedyne, Inc. | LDR |
| May 30, 1984 | K834106 | INTRAVENOUS INFUSION CONTROLLER Cutter Laboratories, Inc. | LDR |
| Mar 30, 1984 | K840942 | IVY COMMANDEER Ivy Medical, Inc. | LDR |
| Mar 23, 1984 | K840823 | TREONIC C30 Vickers America Medical Corp. | LDR |
| Mar 23, 1984 | K840644 | FLO-GARD 4000 VOLUMETRIC INFUSION Travenol Laboratories, S.A. | LDR |
| Feb 21, 1984 | K834528 | MODEL 2001 INTELLIGENT INFUSOR Quest Medical, Inc. | LDR |
| Jan 25, 1984 | K834154 | FLO-GARD 8000 COMPUTER CONTROL INFUSI Travenol Laboratories, S.A. | LDR |
| Dec 29, 1983 | K833953 | ELECTRONIC GRAVITY 300VC Ivent Corp. | LDR |
| Dec 22, 1983 | K833520 | RATEMINDER II SPECIALTY CARE Anatros Corp. | LDR |
| Dec 22, 1983 | K832739 | STEDIFLO INFUSION SET Dravon Medical, Inc. | LDR |
| Nov 28, 1983 | K833682 | PRIMARY PIGGYBACK INFUSION SET W/PERM Cosmetic Sciences, Inc. | LDR |
| Nov 17, 1983 | K832702 | POCKET AID M.C. Johnson Co., Inc. | LDR |
| Apr 8, 1983 | K830780 | KOALA C99 I.V. CONTROLLER Chesebrough-Pond'S U.S.A. Co. | LDR |
| Dec 22, 1982 | K823404 | VOLUMERIC CONTROLLER Quest Medical, Inc. | LDR |
| Nov 24, 1982 | K822891 | FLO CONTROL Dna Medical, Inc. | LDR |
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