Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MEA — Predicate Candidate Screening

31 FDA 510(k) clearances under this product code; the 50 most recent screened below.

97 daysmedian FDA review time

391 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162165	ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and amb	Summit Medical Products, Inc.	2017-08-29	391	5
K170982	CADD®- Solis Ambulatory Infusion Pump with Wireless Communic	Smiths Medical Ads, Inc.	2017-08-24	143	6
K143612	LifeCare PCA Infusion System	Hospira, Inc.	2016-04-08	476	0
K130394	CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0	Smiths Medical Asd, Inc.	2013-12-09	297	2
K092313	PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM	B.Braun Medical, Inc.	2009-11-04	97	3
K072144	CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICAT	Smiths Medical MD, Inc.	2008-03-07	218	7
K051253	MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM)	Baxter Healthcare Corp	2005-07-15	60	2
K043299	MEDLEY PCA MODULE, MODEL 8120	Alaris Medical Systems, Inc.	2004-12-10	10	3
K043256	HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECAR	Hospira, Inc.	2004-12-06	12	3
K042800	LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE	Hospira, Inc.	2004-10-18	10	2
K033054	HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP	Harvard Clinical Technology	2003-12-16	78	2
K032233	MEDLEY PCA MODULE, MODEL 8120	Alaris Medical Systems, Inc.	2003-09-09	50	2
K031566	SYNDEO PCA SYRINGE PUMP, MODEL 2L3113	Baxter Healthcare Corp	2003-08-19	92	1
K030661	STRYKER PAINPUMP2	Stryker Instruments	2003-05-30	88	3
K020418	GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES	P.T. Greenleaf	2003-04-29	446	0
K020421	GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES	Hennig Enterprises Europe Srl	2003-04-29	446	0
K022203	ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384	Abbott Laboratories	2002-08-01	27	2
K013822	MICROJET CRONO PCA	Cane S.R.L.	2002-05-08	173	0
K002739	INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K	Baxter Healthcare Corp	2000-09-11	10	0
K002434	PALM PUMP	Sorenson Medical, Inc.	2000-08-23	14	4
K990312	AVIA PAIN MEDICATION DELIVERY SYSTEM	Amtec Medical	1999-04-22	80	0
K982839	CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300	Sims Deltec, Inc.	1998-11-02	82	0
K943310	MODEL 6100 AMBULATORY INFUSION SYSTEM	Pharmacia Deltec, Inc.	1995-02-21	225	0
K934551	VERIFUSE AMBULATORY PUMP	Block Medical, Inc.	1994-03-17	176	0
K920637	PRIME PCA AND PCA/CONTINUOUS SYSTEMS	Prime Medical Products, Inc.	1993-01-15	338	0
K915270	PATIENT CONTROLLED SYRINGE PUMP TYPE 3300	Graseby Medical , Ltd.	1992-08-24	273	0
K921994	BARD PCA II PUMP WITH PROGRAM CARTRIDGES	C.R. Bard, Inc.	1992-08-03	97	1
K915063	IVAC PC ANIFUSER	Y	1992-06-03	208	0
K914502	BARD PCA II PUMP WITH PROGRAM CARTRIDGES	C.R. Bard, Inc.	1991-12-18	70	1
K910257	BAXA PCA INFUSOR	Baxa Corp., Sub. of Cook Group, Inc.	1991-11-07	289	0
K911791	CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP	Pharmacia Deltec, Inc.	1991-06-11	50	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda