Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

3M Health Care, Sarns · Predicate Candidate Screening

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

71 daysmedian FDA review time

233 days90th percentile

76clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960916	SAMS 8000 CARDIOPLEGIA MONITOR	3M Health Care, Sarns	1996-06-04	90	1
K953901	SARNS 800 ROLLER PUMP	3M Health Care, Sarns	1996-04-19	245	0
K950739	3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V,	3M Health Care, Sarns	1995-11-17	273	0
K941653	SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION	3M Health Care, Sarns	1994-08-24	141	0
K941654	SARNS FILTERED VENOUS RESERVIOR MODIFICATION	3M Health Care, Sarns	1994-07-26	112	0
K940651	SARNS ULTRASONIC AIR SENSOR	3M Health Care, Sarns	1994-05-24	98	0
K935391	SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES	3M Health Care, Sarns	1994-02-24	108	2
K934127	SARNS LOW JETTING AORTIC ARCH CANNULA	3M Health Care, Sarns	1994-02-22	181	41
K935977	SARNS AIR DETECTION SYSTEM	3M Health Care, Sarns	1994-02-04	53	0
K915547	SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT	3M Health Care, Sarns	1993-09-09	638	0
K925075	SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR	3M Health Care, Sarns	1993-06-07	243	0
K925076	SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.	3M Health Care, Sarns	1993-06-07	243	0
K925442	SARNS RETROGRADE CANNULA	3M Health Care, Sarns	1993-05-21	205	5
K920902	MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA	3M Health Care, Sarns	1993-05-11	440	10
K922471	SARNS RETROGRADE CANNULA - AUTO INFLATE	3M Health Care, Sarns	1993-03-12	290	0
K923311	CONDUCER HEAT EXCHANGER	3M Health Care, Sarns	1992-09-18	73	0
K915183	SARNS 8000 MODULAR PERFUSION SYSTEM	3M Health Care, Sarns	1992-07-08	233	45
K915193	SARNS RETROGRADE CANNULA	3M Health Care, Sarns	1992-03-04	106	0
K913176	DELPHIN II CENTRIFUGAL SYSTEM	3M Health Care, Sarns	1991-11-07	113	0
K912079	SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY	3M Health Care, Sarns	1991-10-23	166	0
K912078	SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION	3M Health Care, Sarns	1991-08-20	102	0
K911227	NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS	3M Health Care, Sarns	1991-05-29	70	0
K905686	SARNS TEMPERATURE PROBE AND CONNECTOR	3M Health Care, Sarns	1991-02-25	68	0
K905224	CARDIOPULMONARY BYPASS VASCULAR CATHETER	3M Health Care, Sarns	1991-02-05	77	2
K905638	SARNS INVENT CATHETERS	3M Health Care, Sarns	1991-02-01	45	0
K903436	SARNS MEMBRANE OXGENATOR PART NUMBER 9443	3M Health Care, Sarns	1990-10-19	80	0
K884659	SARNS 9000 WITH CENTRIFUGAL PUMP OPTION	3M Health Care, Sarns	1989-01-24	78	0
K883071	SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM	3M Health Care, Sarns	1988-12-05	138	0
K883603	SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)	3M Health Care, Sarns	1988-11-03	72	3
K882758	CENTRIFUGAL PUMP SYSTEM LX/DX VERSION	3M Health Care, Sarns	1988-10-13	100	7
K883345	SARNS INFANT VENOUS RESERVOIR MODEL #16387	3M Health Care, Sarns	1988-09-28	50	0
K875048	SARNS VENOATRIAL CATHETER	3M Health Care, Sarns	1988-02-18	71	1
K874896	SARNS VISIFLOW AORTIC ARCH CANNULA	3M Health Care, Sarns	1988-02-02	63	1
K873212	SARNS CARDIOPLEGIA/VENT CATHETERS	3M Health Care, Sarns	1987-11-06	84	20
K873813	SARNS WARMER, PART #164975 AND #164980	3M Health Care, Sarns	1987-11-06	49	0
K871131	SARNS 9000 HEART-LUNG CONSOLE	3M Health Care, Sarns	1987-05-21	62	14
K870829	SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR	3M Health Care, Sarns	1987-05-06	64	0
K863902	MODIFIED SARNS MEMBRANE OXYGENATOR	3M Health Care, Sarns	1986-12-11	65	0
K863515	MODIFIED SARNS OXYGENATOR SYSTEM	3M Health Care, Sarns	1986-11-18	69	0
K863593	SARNS SAFETY LOOP	3M Health Care, Sarns	1986-11-18	64	0
K862357	MODIFIED CARDIOTOMY RESERVOIR 5M1470	3M Health Care, Sarns	1986-08-19	57	0
K861388	SARNS PORTABLE POWER MODULE	3M Health Care, Sarns	1986-06-23	70	0
K860702	SARNS FILTERED CARDIOTOMY RESERVOIR	3M Health Care, Sarns	1986-05-28	92	0
K860539	SARNS OXYGENATOR SYSTEM	3M Health Care, Sarns	1986-04-29	76	0
K853516	SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM	3M Health Care, Sarns	1985-11-14	84	0
K853128	SARNS EVACUPLEGE CATHETER	3M Health Care, Sarns	1985-10-17	83	0
K842044	SARNS EVACUPLEGE CATHETER	3M Health Care, Sarns	1984-08-10	81	0
K834134	SARNS 8.0 SOFT ARC CANNULA	3M Health Care, Sarns	1984-04-17	139	1
K834025	SARNS CARDIOPLEGIA CANNULA Y	3M Health Care, Sarns	1984-01-03	42	0
K832417	HYPOTHERMIC MYCARDIAL PROTECTION DEV	3M Health Care, Sarns	1983-10-20	91	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