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

FXY — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

37 daysmedian FDA review time

111 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K222214	ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL	Thi Total Healthcare Innovation GmbH	2023-10-17	449
K200493	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zipper	Stryker Corporation	2020-03-21	22
K140588	FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS	Stryker Corporation	2014-06-26	111
K904969	HOOD, OPERATING, SURGICAL	Chicago Assoc. For Retarded Citizens	1990-12-12	37
K904276	DISPOSABLE BEARD COVER	Anago, Inc.	1990-11-21	63
K903533	STERI-SHIELD	Biomedical Devices, Inc.	1990-10-19	74
K902677	STERI-SHIELD	Biomedical Devices, Inc.	1990-08-17	60
K880431	CARETEX SURGEON'S HOODS	James River Corp.	1988-02-24	23
K770261	HOOD, CLARION SURGEONS	Sherwood Medical Industries	1977-03-01	18
K770257	HOOD & BEARD COVER, CLARION SURGEON'S	Sherwood Medical Industries	1977-02-25	14
K761070	P.S.M. SURGICAL HOOD	The Owenby Co.	1976-12-30	44
K760865	BARRIER FASHION BONNET	Surgikos, Inc.	1976-11-03	16
K760855	BARRIER SURGICAL HOOD	Surgikos, Inc.	1976-11-03	19

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