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

Gainor Medical · Predicate Candidate Screening

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

165 daysmedian FDA review time

240 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K850100	BLOOD LANCET	Gainor Medical	1987-01-29	748
K850150	ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED	Gainor Medical	1985-02-21	38
K844306	GAINOR MEDICAL SYRINGE	Gainor Medical	1984-11-30	24
K844305	GAINOR MEDICAL FLOWMAX NEEDLES	Gainor Medical	1984-11-30	24
K840951	FIRST AID BANDAGE	Gainor Medical	1984-10-31	240
K840950	ZINC OXIDE TAPE	Gainor Medical	1984-10-31	240
K840945	SKIN CLOSURE	Gainor Medical	1984-10-31	240
K840946	MICROPOROUS HYPOALLERGENIC	Gainor Medical	1984-08-17	165
K840949	CLEAR PLASTIC-HYPOALLERGENIC	Gainor Medical	1984-08-17	165
K840947	CLOTH-HYPOALLERGENIC	Gainor Medical	1984-08-17	165
K840948	CLEAR POROUS PLASTIC-HYPOALLERGENIC	Gainor Medical	1984-08-14	39

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