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

Med-Logics, Inc. — Predicate Candidate Screening

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

85 daysmedian FDA review time

154 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033293	MED-LOGICS, MODEL ML7090	Med-Logics, Inc.	2004-01-13	91	1
K022982	MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB	Med-Logics, Inc.	2002-11-15	67	0
K022716	MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB	Med-Logics, Inc.	2002-10-11	57	0
K010872	ML BLADE, MODEL ML7030	Med-Logics, Inc.	2001-06-22	91	0
K010353	MED-LOGICS DISPOSABLE ALK TUBING	Med-Logics, Inc.	2001-04-27	80	0
K002515	MEDLOGICS ML 4000, MODEL 4000	Med-Logics, Inc.	2001-02-22	191	0
K002279	ML EYE SPEAR, MODEL ML 27 ES	Med-Logics, Inc.	2000-08-18	23	0
K983448	ML UNIVERSAL TUBING	Med-Logics, Inc.	1998-12-18	79	0
K981071	ML MICROKERATOME	Med-Logics, Inc.	1998-07-23	121	0
K972522	ML-DISPOSABLE PAK	Med-Logics, Inc.	1997-09-30	85	0
K971173	ML DISPOSABLE ALK TUBING	Med-Logics, Inc.	1997-05-22	52	0
K962661	ML MICROKERATOME BLADE	Med-Logics, Inc.	1996-12-09	154	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