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

Edwards Laboratories — Predicate Candidate Screening

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

21 daysmedian FDA review time

58 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K801552	MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR	Edwards Laboratories	1980-07-28	20
K800655	MODEL 100 SPECTRAVIEW	Edwards Laboratories	1980-04-16	22
K792441	CARPENTIER-EDWARDS FLEX. ANNULOPLASTY	Edwards Laboratories	1980-03-17	109
K792034	INTEGRAL DISPOSABLE HOLDER CARPENTIER	Edwards Laboratories	1979-12-07	58
K790047	CARDIAC OUTPUT COMPUTER, MDEL 9520A	Edwards Laboratories	1979-02-26	52
K790022	DISPOSABLE HOLDER FOR BIOPROSTHESIS	Edwards Laboratories	1979-01-15	12
K781535	AC ADAPTER:MODELS 9525,9526,9527	Edwards Laboratories	1978-09-15	9
K771663	PROBE & CATHETER	Edwards Laboratories	1977-09-20	21
K771046	VENA CAVA UMBRELLA FILTER, MODEL 7321	Edwards Laboratories	1977-06-22	12
K760151	APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)	Edwards Laboratories	1976-08-26	56
K760152	FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)	Edwards Laboratories	1976-07-19	18
K760192	COMPUTER, THERMODILUTION CARDIAC (9520)	Edwards Laboratories	1976-07-19	13

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