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

Baxter Healthcare Corp · Predicate Candidate Screening

505 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time

273 days90th percentile

505clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190910	PrisMax System Version 2	Baxter Healthcare Corp	2019-07-25	108	3
K163530	PrisMax Control Unit	Baxter Healthcare Corp	2017-05-03	138	0
K130531	ULTRAFUSE	Baxter Healthcare Corp	2014-04-08	403	0
K132734	NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNE	Baxter Healthcare Corp	2013-10-08	35	1
K130245	LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE	Baxter Healthcare Corp	2013-03-01	29	1
K123874	INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BU	Baxter Healthcare Corp	2013-01-10	24	3
K123868	INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECOND	Baxter Healthcare Corp	2013-01-08	22	0
K121092	FLOWEASE [SUBCUTANEOUS] INFUSION SET	Baxter Healthcare Corp	2012-06-29	80	0
K113227	NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER	Baxter Healthcare Corp	2011-12-08	37	0
K111217	ADDITIVE CAP	Baxter Healthcare Corp	2011-06-14	43	0
K102936	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONE	Baxter Healthcare Corp	2011-03-30	177	7
K103551	INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD	Baxter Healthcare Corp	2011-03-25	113	1
K103245	CELSTAT	Baxter Healthcare Corp	2011-03-23	141	0
K101385	DUAL LUER LOCK CAP, MODEL 2C6250	Baxter Healthcare Corp	2010-06-22	35	0
K090002	ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONC	Baxter Healthcare Corp	2009-08-07	217	0
K081717	TRICOS A RESORBABLE BONE SUBSTITUTE	Baxter Healthcare Corp	2008-10-10	114	0
K081721	TRICOS A RESORBABLE SUBSTITUTE	Baxter Healthcare Corp	2008-08-06	49	0
K081289	V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SET	Baxter Healthcare Corp	2008-08-04	89	0
K072576	CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTE	Baxter Healthcare Corp	2007-11-06	54	0
K071222	INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES	Baxter Healthcare Corp	2007-05-25	23	4
K070125	COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT H	Baxter Healthcare Corp	2007-04-16	90	0
K052973	IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K	Baxter Healthcare Corp	2007-01-25	458	0
K061515	RENALSOFT	Baxter Healthcare Corp	2006-09-11	102	2
K060074	INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326	Baxter Healthcare Corp	2006-03-29	78	0
K053512	HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSI	Baxter Healthcare Corp	2006-02-16	62	3
K051722	TRICOS T	Baxter Healthcare Corp	2005-11-18	144	0
K051370	STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CAR	Baxter Healthcare Corp	2005-08-12	78	0
K051253	MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM)	Baxter Healthcare Corp	2005-07-15	60	2
K040985	PUMP CONNECTIVITY INTERFACE	Baxter Healthcare Corp	2004-11-30	229	0
K042936	SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE	Baxter Healthcare Corp	2004-11-26	32	0
K042410	BAXJECT II	Baxter Healthcare Corp	2004-10-08	31	0
K041428	ACCUSOL DIALYSIS SOLUTION	Baxter Healthcare Corp	2004-08-27	91	0
K041191	COLLEAGUE VOLUMETRIC INFUSION PUMPS	Baxter Healthcare Corp	2004-06-25	50	10
K031676	HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4	Baxter Healthcare Corp	2003-11-20	174	2
K031882	ENDOSCOPIC APPLICATOR	Baxter Healthcare Corp	2003-09-05	79	0
K031566	SYNDEO PCA SYRINGE PUMP, MODEL 2L3113	Baxter Healthcare Corp	2003-08-19	92	1
K030099	BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000	Baxter Healthcare Corp	2003-06-17	158	5
K030974	EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170	Baxter Healthcare Corp	2003-04-25	28	0
K030975	EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210	Baxter Healthcare Corp	2003-04-25	28	0
K023664	SYNTRA + DIALYZER, MODEL 200	Baxter Healthcare Corp	2003-02-21	113	0
K013562	AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELI	Baxter Healthcare Corp	2002-12-12	412	2
K021615	BAXTER ACCURA SYSTEM, MODEL 5M5660	Baxter Healthcare Corp	2002-11-18	186	3
K020666	DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML	Baxter Healthcare Corp	2002-06-24	115	1
K014088	DUPLOREACH	Baxter Healthcare Corp	2002-06-07	177	0
K021274	PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MO	Baxter Healthcare Corp	2002-05-17	25	0
K020485	ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML	Baxter Healthcare Corp	2002-03-12	27	0
K012988	HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODEL	Baxter Healthcare Corp	2001-12-05	90	9
K011317	MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE	Baxter Healthcare Corp	2001-06-28	59	1
K010566	COLLEAGUE VOLUMETRIC INFUSION PUMP	Baxter Healthcare Corp	2001-05-15	78	2
K003747	C1-INHIBITOR MICROTITER ASSAY DEVICE	Baxter Healthcare Corp	2001-03-19	105	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