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

Opus Medical, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time

186 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K042584	OPUS MINIMAGNUM ANCHOR WITH INSERTER	Opus Medical, Inc.	2004-12-14	83	3
K042914	OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE	Opus Medical, Inc.	2004-11-12	22	0
K042031	OPUS SPEEDSTITCH SUTURE DEVICE	Opus Medical, Inc.	2004-10-19	83	1
K041440	OPUS MAGNUM ANCHOR WITH INSERTER	Opus Medical, Inc.	2004-06-25	24	0
K033317	SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-	Opus Medical, Inc.	2003-12-30	76	0
K030170	REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500	Opus Medical, Inc.	2003-07-28	192	0
K031083	OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500	Opus Medical, Inc.	2003-06-12	69	0
K030235	F1 DIODE LASER SYSTEM	Opus Medical, Inc.	2003-04-23	90	0
K023843	SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATIO	Opus Medical, Inc.	2003-02-14	88	0
K022229	SMARTSTITCH SUTURE DEVICE, MODEL OM-8500	Opus Medical, Inc.	2002-09-06	58	3
K020172	OPUS MAGNUM ANCHOR & INSTRUMENT SET	Opus Medical, Inc.	2002-07-22	186	0
K012125	OPUS MAGNUM ANCHOR & INSERTER	Opus Medical, Inc.	2001-09-17	73	0
K004021	F1 DIODE LASER SYSTEM	Opus Medical, Inc.	2001-03-27	90	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