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

Glycar, Inc. — Predicate Candidate Screening

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

176 daysmedian FDA review time

430 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K963368	GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULA	Glycar, Inc.	1997-10-31	430	0
K963967	GLYCAR PERICARDIAL PATCH	Glycar, Inc.	1997-10-31	394	2
K963175	GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING	Glycar, Inc.	1996-09-23	40	0
K954665	GLYCAR STAPLE STRIPS	Glycar, Inc.	1996-02-14	127	0
K942911	GLYCAR TISSUE REPAIR PATCH	Glycar, Inc.	1994-12-14	176	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