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

Bioseal — Predicate Candidate Screening

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

37 daysmedian FDA review time

108 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K893814	SURGICAL INSTRUMENT KIT, DISPOSABLE	Bioseal	1989-08-10	79	0
K882695	RUBBER BAND, STERILE	Bioseal	1988-10-13	108	0
K882696	DERMICEL, MONTGOMERY STRAP	Bioseal	1988-08-26	60	0
K882694	FIXATION DEVICE, TRACH TUBE	Bioseal	1988-08-15	49	0
K882712	STICK SPONGE	Bioseal	1988-08-03	37	0
K882708	GAUZE SPONGE, X-RAY DETECTABLE	Bioseal	1988-08-03	37	4
K882711	GAUZE SPONGE 12PLY	Bioseal	1988-08-03	37	0
K882709	TONSIL SPONGE, X-RAY DETECTABLE, W/STRING	Bioseal	1988-08-03	37	0
K882710	INTESTINAL SPONGES	Bioseal	1988-08-03	37	0
K882707	GAUZE PACKING, X-RAY DETECTABLE	Bioseal	1988-08-03	37	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