Atlas FDA

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

The Sewing Source, Inc. · Predicate Candidate Screening

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

492 daysmedian FDA review time
492 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960045ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPEThe Sewing Source, Inc.1996-06-051550
K921151O.R./SURGEONS GOWN, ITEM NO. 4951The Sewing Source, Inc.1993-07-094920
K921153O.R./SURGEONS GOWN, ITEM NO. 4960The Sewing Source, Inc.1993-07-094920
K921156O.R./SURGEONS GOWN, ITEM NO.4941The Sewing Source, Inc.1993-07-094920
K921154O.R./SURGEONS GOWN, ITEM NO. 4962The Sewing Source, Inc.1993-07-094920
K921158O.R./SURGEONS GOWN, ITEM NO. 4950The Sewing Source, Inc.1993-07-094920
K921157O.R./SURGEONS GOWN, ITEM NO. 4942The Sewing Source, Inc.1993-07-094920
K921155O.R./SURGEONS GOWN, ITEM NO. 4962The Sewing Source, Inc.1993-07-094920
K921152O.R./SURGEONS GOWN, ITEM NO. 4952The Sewing Source, Inc.1993-07-094920

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