Atlas FDA

LDR

60 FDA 510(k) clearances · Product code

57 daysmedian time to decision
183 days90th percentile
60clearances measured

FDA profile

Official device name
Controller, Infusion, Intravascular, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
1995: 5 · 1996: 10 · 1997: 8 · 1998: 6 · 2004: 2 · 2018: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DEKA Infusion System, DEKA Administration Set (K242693)Deka Research and Development Corporation2024-10-07
DEKA Infusion System, DEKA Administration Set (K232316)Deka Research and Development2024-03-01
Volumetric Infusion Controller (K153760)DEKA Research & Development2016-10-03
PACER MODEL 100 INFUSION CONTROLLER (K963136)Health Watch, Inc.1997-10-10
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (K971865)Alexander Mfg. Co.1997-07-03
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (K971826)Alexander Mfg. Co.1997-07-03
UNIVERSAL CONTROLLER, MODEL 100 (K934543)Metamed, Inc.1994-03-29
FLOW CONTROLLING EXTENSION SET (K935236)Block Medical, Inc.1994-02-24
MASTER FLOW I.V. PUMPETTE (K905497)The Master Medical Corp.1991-04-16
STAT 2 IV PUMPETTE (K905498)The Master Medical Corp.1991-04-16
3M IV FLOW REGULATOR (K896907)3M Company1990-02-26
VARI-SET (K894111)Sonex Medical1989-09-28
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ (K894487)Y1989-09-27
LIFECARE 75 CONTROLLER (K893487)Abbott Laboratories1989-07-28
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 (K884307)Y1988-11-01
IVY COMMANDER, MODEL 600 (K882167)Ivy Medical, Inc.1988-09-23
STA-SET I.V. FLOW REGULATOR (K880006)Controlled Flow , Ltd.1988-03-24
TECHNICON CHEM 1(TM) SYSTEM (K874916)Technicon Instruments Corp.1988-03-03
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 (K874481)Y1988-03-03
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ (K874491)Y1988-02-25
IVY COMMANDER (MODEL 500) (K870820)Ivy Medical, Inc.1988-01-20
IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 (K870317)Y1987-04-03
IVAC FLOW CONTROL ADMINISTRATION SET (K870132)Y1987-02-05
BETAFLO 2000 PIGGYBACK SYSTEM (K864789)Betaflo, Inc.1987-02-04
STA-SET MODEL 250 I.V. FLOW REGULATOR (K864229)Sta-Set Corp.1986-12-16
DEKA JR. (K863204)Deka Research & Development Corp.1986-09-03
BETAFLO 2000 (K862273)Betaflo, Inc.1986-07-18
RATEMINDER III INFUSION DEVICE (K855000)American Edwards Laboratories1986-02-12
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER (K854863)Travenol Laboratories, S.A.1986-02-12
DOSI FLOW (K851058)Leventon, S.A.1985-04-29
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR (K842209)Armour Pharmaceutical Co.1984-12-04
DK*300 VOLUMETRIC INFUSION CONTROLLER (K843254)Deka Research & Development Corp.1984-10-11
IVAC 280 VOLUMETRIC INFUSION CONTROLLER (K842419)Y1984-08-07
IVENT 302VC DUAL CONTROLLER (K842210)Ivent Corp.1984-07-25
A.S.A.P. (K841318)Trimedyne, Inc.1984-07-18
ABBOTT LIFECARE 1050 CONTROLLER (K842080)Abbott Laboratories1984-07-18
INTRAVENOUS INFUSION CONTROLLER (K834106)Cutter Laboratories, Inc.1984-05-30
IVY COMMANDEER (K840942)Ivy Medical, Inc.1984-03-30
FLO-GARD 4000 VOLUMETRIC INFUSION (K840644)Travenol Laboratories, S.A.1984-03-23
TREONIC C30 (K840823)Vickers America Medical Corp.1984-03-23
MODEL 2001 INTELLIGENT INFUSOR (K834528)Quest Medical, Inc.1984-02-21
FLO-GARD 8000 COMPUTER CONTROL INFUSI (K834154)Travenol Laboratories, S.A.1984-01-25
ELECTRONIC GRAVITY 300VC (K833953)Ivent Corp.1983-12-29
RATEMINDER II SPECIALTY CARE (K833520)Anatros Corp.1983-12-22
STEDIFLO INFUSION SET (K832739)Dravon Medical, Inc.1983-12-22
PRIMARY PIGGYBACK INFUSION SET W/PERM (K833682)Cosmetic Sciences, Inc.1983-11-28
POCKET AID (K832702)M.C. Johnson Co., Inc.1983-11-17
KOALA C99 I.V. CONTROLLER (K830780)Chesebrough-Pond'S U.S.A. Co.1983-04-08
VOLUMERIC CONTROLLER (K823404)Quest Medical, Inc.1982-12-22
FLO CONTROL (K822891)Dna Medical, Inc.1982-11-24
380 PIGGYBACK CONTROLLER (K823026)Imed Corp.1982-11-22
PERMA-SET INFUSION SET (K822603)Cosmetic Sciences, Inc.1982-09-14
SKIN SCRUB-TRAY (K821579)Associated Medical Products Co.1982-07-21
TRAVENOL INFUSION CONTROLLER 2M8052 (K812510)Travenol Laboratories, S.A.1981-09-16
RATEMINDER (K812233)Anatros Corp.1981-08-25
LIFECARE 1000 CONTROLLER (K812114)Abbott Laboratories1981-08-20
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE (K811432)Millipore Corp.1981-07-13
IVAC 260 SERIES VOLUME TRIC INFUSION CON (K801861)Y1980-08-27
ID BRACLETS, ADULT & INFANT (K771158)Divers-A-Med1977-10-13
TUMBLER, GENERAL MEDICAL MEDI-PAK (K760491)Landmark Plastics1976-09-15

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Every clearance here is in the API, with alerts when new ones post.