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

Bemis Health Care — Predicate Candidate Screening

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

32 daysmedian FDA review time

57 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K885019	BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.	Bemis Health Care	1989-01-25	57
K822556	CRITICAL MEASUREMENT UNIT	Bemis Health Care	1982-10-18	55
K822557	SPECIMEN ADAPTOR	Bemis Health Care	1982-10-18	55
K803206	SUCTION PROBE	Bemis Health Care	1981-01-21	35
K771737	SUCTION CANISTER	Bemis Health Care	1977-12-20	96
K771738	MALE URINAL	Bemis Health Care	1977-09-28	13
K771733	8 EMESIS BASIN	Bemis Health Care	1977-09-28	13
K760393	BED PAN, STACKABLE (AUTOCLAVABLE)	Bemis Health Care	1976-08-23	17
K760072	CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR	Bemis Health Care	1976-07-20	32
K760073	BASIN, WASH, 6-QT RECTANGULAR	Bemis Health Care	1976-07-20	32
K760070	TUMBLER, PERSONAL, ROUND, 9 OUNCE	Bemis Health Care	1976-07-20	32
K760071	TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4	Bemis Health Care	1976-07-20	32

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