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

Sorin Biomedica, Fiat, USA, Inc. · Predicate Candidate Screening

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

140 daysmedian FDA review time

242 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K931444	PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS	Sorin Biomedica, Fiat, USA, Inc.	1994-05-27	431	0
K925661	STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE	Sorin Biomedica, Fiat, USA, Inc.	1993-05-18	189	0
K925369	BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS	Sorin Biomedica, Fiat, USA, Inc.	1993-03-26	154	0
K925615	SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE	Sorin Biomedica, Fiat, USA, Inc.	1993-03-26	140	5
K924354	STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR	Sorin Biomedica, Fiat, USA, Inc.	1993-02-18	190	0
K925541	STOCKERT 1/4 BUBBLE SENSOR	Sorin Biomedica, Fiat, USA, Inc.	1993-02-02	91	0
K922933	SORIN MONOLYRH INTEGRATED MEMBRANE LUNG	Sorin Biomedica, Fiat, USA, Inc.	1992-11-30	165	0
K854963	S80 IMPLANTABLE CARDIAC PACING LEAD	Sorin Biomedica, Fiat, USA, Inc.	1986-06-24	195	0
K852641	ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER	Sorin Biomedica, Fiat, USA, Inc.	1986-01-14	208	0
K851365	SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM	Sorin Biomedica, Fiat, USA, Inc.	1985-12-03	242	0
K841947	ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT	Sorin Biomedica, Fiat, USA, Inc.	1984-06-25	42	0
K841948	TESTOSTERONE DIRECT RADIOIMMUNOASSAY	Sorin Biomedica, Fiat, USA, Inc.	1984-06-25	42	0
K841573	INSULIN RADIOIMMUNOASSAY KIT	Sorin Biomedica, Fiat, USA, Inc.	1984-05-16	29	0
K832694	DIRIA-PROGK IMMUNOASSAY	Sorin Biomedica, Fiat, USA, Inc.	1984-01-11	154	0
K833768	C. PTH RADIOIMMUNOASSAY KIT-CPTHK	Sorin Biomedica, Fiat, USA, Inc.	1983-12-29	63	0
K830563	CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK	Sorin Biomedica, Fiat, USA, Inc.	1983-05-13	79	0
K800773	DIGOCTK 125	Sorin Biomedica, Fiat, USA, Inc.	1980-04-24	17	0
K800774	RENCTK	Sorin Biomedica, Fiat, USA, Inc.	1980-04-21	14	0
K800775	ALDOCTK-125	Sorin Biomedica, Fiat, USA, Inc.	1980-04-21	14	0
K800776	TESTOK-125	Sorin Biomedica, Fiat, USA, Inc.	1980-04-21	14	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