Atlas FDA

MRZ

48 FDA 510(k) clearances · Product code

92 daysmedian time to decision
288 days90th percentile
48clearances measured

FDA profile

Official device name
Accessories, Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2020: 44 · 2021: 61 · 2022: 39 · 2023: 27 · 2024: 41 · 2025: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
UTC 3mL Medication Cartridge (K230718)Gilero, LLC2023-06-15
Elite Biomedical Solutions Dose Request Cord (K220695)Elite Biomedical Solutions2022-04-29
RG 3ml Medication Cartridge (K201634)Chengdu Shifeng Medical Technology Co., Ltd.2021-03-26
BlueStar Rx (K193654)Welldoc, Inc.2020-04-07
SpaceStation MRI (K191910)B. Braun Melsugen AG2020-03-12
WellDoc BlueStar (K190013)Welldoc, Inc.2019-11-04
Lockbox for Perfusor Space PCA Infusion Pump (K173531)B.Braun Medical, Inc.2018-08-02
Sapphire Sets (K171346)Icu Medical2017-08-25
WellDoc BlueStar, WellDoc BlueStar Rx (K162532)Welldoc, Inc.2017-01-12
Hospira Sapphire Sets (K160492)Hospira, Inc.2016-12-06
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (K162225)Welldoc, Inc.2016-11-22
ivWatch Model 400 (K142374)Ivwatch, LLC2015-02-13
SMART LABEL, PROPOFOL (K142333)American I.V. Products, Inc. Dba Aiv, Inc.2014-12-18
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE (K141273)Welldoc, Inc.2014-07-08
ONETOUCH REVEAL (K132618)Lifescan, Inc.2013-12-16
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE (K120209)American I.V. Products, Inc.2012-04-12
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (K120314)Welldoc, Inc.2012-02-24
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (K112370)Welldoc, Inc.2011-10-14
AIDERA DIASEND SYSTEM (K101806)Aidera AB2010-12-07
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (K100066)Welldoc, Inc.2010-07-15
LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS (K091181)Smiths Medical MD, Inc.2009-06-12
AIDERA DIASEND (K083221)Aidera AB2009-02-03
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE (K082783)Smiths Medical MD, Inc.2008-12-17
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM (K080227)Roche Diagnostics Corp.2008-05-15
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587)Animas Corp.2008-05-15
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) (K072955)Smiths Medical MD, Inc.2008-02-13
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438)Medtronic Minimed, Inc.2007-10-17
DANA 3CC SYRINGE INSULIN RESERVOIR (K071418)Sooil Development Co., Ltd.2007-09-04
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY (K051079)Hospicare, Inc.2005-05-19
RITA CLIPS FOR INFUSION PUMPS (K030936)Rita Medical Systems, Inc.2003-04-01
PREPARE CARTRIDGE (K023890)Appro Healthcare, Inc.2003-02-07
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 (K021974)Minimed, Inc.2002-08-06
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (K012266)National Custom Ent., Inc.2001-09-12
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (K012262)National Custom Ent., Inc.2001-09-12
MEDFUSION 2001 & 2010, MODEL N7215IWC (K012259)National Custom Ent., Inc.2001-09-12
S.P.A.R STERILE AMBULATORY RESERVOIR (K990091)Faulding Pharmaceutical Co.1999-04-04
INFUTEST 2000 INFUSION DEVICE ANALYZER (K980165)Datrend Systems, Inc.1998-04-20
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT (K961486)Ivac Medical Systems1998-04-17
THE HARVARD LIBRARY (K970678)Harvard Apparatus, Inc.1998-01-09
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P (K972779)Alexander Mfg. Co.1997-10-20
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 (K972780)Alexander Mfg. Co.1997-10-20
STERILE AMBULATORY RESERVOIR 60ML/100ML (K962159)Faulding Medical Device Co.1997-07-18
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 (K972089)Alexander Mfg. Co.1997-07-03
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P (K971213)Alexander Mfg. Co.1997-05-27
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 (K971237)Alexander Mfg. Co.1997-05-27
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 (K971212)Alexander Mfg. Co.1997-05-27
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) (K970786)Alexander Mfg. Co.1997-05-27
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 (K971234)Alexander Mfg. Co.1997-05-27

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