Atlas FDA

MEA

31 FDA 510(k) clearances · Product code

97 daysmedian time to decision
391 days90th percentile
31clearances measured

FDA profile

Official device name
Pump, Infusion, Pca
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 3,776 · 2022: 6,443 · 2023: 3,984 · 2024: 4,560 · 2025: 3,330 · 2026: 1,755
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165)Summit Medical Products, Inc.2017-08-29
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982)Smiths Medical Ads, Inc.2017-08-24
LifeCare PCA Infusion System (K143612)Hospira, Inc.2016-04-08
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (K130394)Smiths Medical Asd, Inc.2013-12-09
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313)B.Braun Medical, Inc.2009-11-04
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144)Smiths Medical MD, Inc.2008-03-07
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)Baxter Healthcare Corp2005-07-15
MEDLEY PCA MODULE, MODEL 8120 (K043299)Alaris Medical Systems, Inc.2004-12-10
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800)Hospira, Inc.2004-10-18
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
MEDLEY PCA MODULE, MODEL 8120 (K032233)Alaris Medical Systems, Inc.2003-09-09
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)Baxter Healthcare Corp2003-08-19
STRYKER PAINPUMP2 (K030661)Stryker Instruments2003-05-30
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020418)P.T. Greenleaf2003-04-29
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020421)Hennig Enterprises Europe Srl2003-04-29
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 (K022203)Abbott Laboratories2002-08-01
MICROJET CRONO PCA (K013822)Cane S.R.L.2002-05-08
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K (K002739)Baxter Healthcare Corp2000-09-11
PALM PUMP (K002434)Sorenson Medical, Inc.2000-08-23
AVIA PAIN MEDICATION DELIVERY SYSTEM (K990312)Amtec Medical1999-04-22
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 (K982839)Sims Deltec, Inc.1998-11-02
MODEL 6100 AMBULATORY INFUSION SYSTEM (K943310)Pharmacia Deltec, Inc.1995-02-21
VERIFUSE AMBULATORY PUMP (K934551)Block Medical, Inc.1994-03-17
PRIME PCA AND PCA/CONTINUOUS SYSTEMS (K920637)Prime Medical Products, Inc.1993-01-15
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 (K915270)Graseby Medical , Ltd.1992-08-24
BARD PCA II PUMP WITH PROGRAM CARTRIDGES (K921994)C.R. Bard, Inc.1992-08-03
IVAC PC ANIFUSER (K915063)Y1992-06-03
BARD PCA II PUMP WITH PROGRAM CARTRIDGES (K914502)C.R. Bard, Inc.1991-12-18
BAXA PCA INFUSOR (K910257)Baxa Corp., Sub. of Cook Group, Inc.1991-11-07
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP (K911791)Pharmacia Deltec, Inc.1991-06-11

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