Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NWJ — Predicate Candidate Screening

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

73 daysmedian FDA review time
272 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc.2021-05-27280
K132348TEPHAFLEX BRAIDED SUTURETepha, Inc.2013-09-05380
K130422PHANTOM FIBER BIOFIBER SUTURETornier, Inc.2013-04-04430
K122487BIOFIBER SYTURETornier, Inc.2012-09-17330
K100876AESCULAP MONOMAX ABSORBABLE SUTUREAesculap, Inc.2010-07-141060
K082178TEPHAFLEX ABSORBABLE SUTURETepha, Inc.2008-10-30900
K081099TEPHAFLEX ABSORBABLE SUTURETepha, Inc.2008-07-15890
K072470BIOELAST 5-0 SUTURE, MODEL 500100Entrigue Surgical, Inc.2007-11-16730
DEN060003TEPHAFLEX ABSORBABLE SUTURETepha, Inc.2007-02-082720

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