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

HMY — Predicate Candidate Screening

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

67 daysmedian FDA review time

108 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040297	ONEUSE- PLUS MICROKERATOME	Moria SA	2004-03-31	51	0
K023092	BD K-4000 MICROKERATOME SYSTEM	Becton, Dickinson & CO	2002-10-18	30	1
K022637	BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME	Becton, Dickinson & CO	2002-10-16	69	1
K022560	M2 SINGLE USE MICROKERTOME	Moria SA	2002-09-27	56	0
K003594	CARRIAZO BARRAQUER SINGLE USE MICROKERATOME	Moria, Inc.	2001-03-09	108	0
K002191	CARRIAZO BARRAQUER II MICROKERATOME	Moria, Inc.	2000-10-12	84	0
K992687	MILLENIUM MICROKERATOME, MODEL IMD-001	Industrial & Medical Design, Inc.	1999-09-24	45	0
K984537	KERATOME SYSTEM, MODEL K3000	Insight Technologies Instruments, LLC	1999-05-14	144	0
K981741	CARRIAZO BARRAQUER MICROKERATOME	Moria, Inc.	1998-07-24	67	0
K974243	KERATOME SYSTEM	Insight Technologies Instruments, LLC	1998-01-20	69	0
K902857	VISI-DRAPE OPHTHALMIC DRAPES	Visitec Co.	1990-07-31	32	0
K781412	OSCILLATING KNIFE AND ACCESSORIES	Codman & Shurtleff, Inc.	1978-10-11	57	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