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

NBY — Predicate Candidate Screening

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

118 daysmedian FDA review time

268 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K231277	TissueStat	Durastat, LLC	2023-11-09	190
K192088	GOLNIT Non-aborbable PTFE Surgical Suture	Antarma, LLC Dba Golnit Sutures	2019-09-04	30
K180992	Biotex	Purgo Biologics, Inc.	2019-07-16	456
K191317	StitchKit	Origami Surgical	2019-07-12	58
K181578	DemeTECH PTFE Nonabsorbable Surgical Suture	Demetech Corporation	2018-10-11	118
K180630	PTFE SURGICAL SUTURE	Omnia Spa	2018-04-06	28
K173922	C-PTFETM Surgical Suture	Cp Medical, Inc.	2018-03-26	90
K173335	Gazelle PTFE and Suture Delivery Device	Dura Tap, LLC	2018-02-08	108
K170842	WEGO-PTFE	Foosin Medical Supplies Inc., Ltd.	2017-07-31	132
K163049	GOLNIT Non-Absorbable PTFE Surgical Suture	Antarma Dba Golnit Sutures	2017-06-21	232
K163639	LS-5 ePTFE Suture	Lsi Solutions	2017-06-02	161
K160744	LOOK PTFE Suture	Surgical Specialties Corporation	2016-07-13	118
K140415	MONOTEX	Riverpoint Medical	2014-03-26	36
K132464	PTFE SURGICAL SUTURE	Omnia Spa	2014-02-12	189
K123811	STITCHKIT	Origami Surgical, LLC	2013-09-05	268
K072076	CYTOPLAST PTFE SUTURE	Osteogenics Biomedical, Inc.	2007-10-31	93
K003028	CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-051	Osteogenics Biomedical, Inc.	2000-11-24	57

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