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

LRN · Predicate Candidate Screening

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

103 daysmedian FDA review time

196 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K002755	NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE	T. Korossurgical Instruments Corp.	2000-12-04	90
K990355	STAINLESS STEEL SOFT SUTURE WIRE	Bregma International Trading Company , Ltd.	1999-07-08	153
K971682	J-FX CERCLAGE SYSTEM	Johnson & Johnson Professionals, Inc.	1997-06-27	52
K952783	OXBORO-MEDICAL PIN COVERS	Oxboro Medical Intl., Inc.	1995-09-15	88
K942603	ORTHOPAEDIC WIRES	Acu Med, Inc.	1994-11-09	161
K900926	TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)	Howmedica Corp.	1990-04-23	55
K892651	SONGER WIRING SYSTEM	Danek Medical, Inc.	1989-07-25	103
K864375	TYPE 316L COTTER WIRE	Winn Hirsch & Assoc.	1987-05-20	196

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