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

Johnson & Johnson International — Predicate Candidate Screening

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

141 daysmedian FDA review time

383 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K965198	ULTIMA TPS CEMENTED STEM	Johnson & Johnson International	1997-07-23	209	0
K944937	SYNTHETIC ABSORBABLE SUTURE	Johnson & Johnson International	1995-05-19	225	0
K946245	TIELLE* HYDROPOLYMER DRESSING	Johnson & Johnson International	1995-04-11	110	0
K942383	DERMIVIEW CLEAR TAPE	Johnson & Johnson International	1994-08-22	95	0
K922918	BARRIER SAF-TE HYDROGEL DRAPE	Johnson & Johnson International	1993-07-06	383	0
K923807	P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS	Johnson & Johnson International	1992-11-09	103	1
K896828	BIOCLUSIVE(R) ABSORBENT DRESSING	Johnson & Johnson International	1990-11-21	352	0
K901456	ORTHOSORB(R) ABSORBABLE PIN	Johnson & Johnson International	1990-08-15	141	0
K900638	P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT	Johnson & Johnson International	1990-04-30	80	0
K895207	BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM	Johnson & Johnson International	1989-09-28	42	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