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

Convertors — Predicate Candidate Screening

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

48 daysmedian FDA review time

453 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K780627	SURG-O-PAK, GOWNS, SHEETS, AND TOWELS	Convertors	1979-07-11	453
K790234	DRAPE PACKS, SURGICAL GOWNS	Convertors	1979-02-22	20
K781959	SURGICAL GOWNS, SHEETS	Convertors	1979-01-10	50
K781534	SURG-O-PAK PREP PAD	Convertors	1978-10-24	48
K781099	SURGICAL GOWNS AND DRAPES	Convertors	1978-08-14	42
K780169	MASK, SURGICAL	Convertors	1978-02-13	11
K771929	PEDIATRICS GOWN	Convertors	1977-11-16	33
K770933	BIO-SHIELD CSR WRAP	Convertors	1977-09-02	102
K770346	ORTHOPEDIC STOCKINETTE	Convertors	1977-03-07	13
K761034	SURGEX SURGICAL SPONGE	Convertors	1977-01-05	51

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