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

MML — Predicate Candidate Screening

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

87 daysmedian FDA review time

244 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170591	Altomed Malhotra Platinum Segments	Altomed Limited	2017-06-06	98	0
K150986	Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Im	Meddev Corporation	2015-08-17	125	2
K021750	LID CHAIN EYELID WEIGHTS	Jedmed Instrument Co.	2003-01-27	244	0
K011740	CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SE	Meddev Corp.	2001-07-02	27	0
K011115	KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4	Heinz Kurz GmbH Medizintechnik	2001-05-02	20	0
K003646	SUTUREGROOVE WEIGHT SIZING SET	Iop, Inc.	2001-02-22	87	0
K001123	KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111	Heinz Kurz GmbH Medizintechnik	2000-04-21	14	0
K994289	SUTUREGROOVE	Iop, Inc.	2000-04-17	118	0
K000127	KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 400	Heinz Kurz GmbH Medizintechnik	2000-04-12	85	0
K990224	LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET	Labtician Ophthalmics, Inc.	1999-04-12	77	0
K983607	LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS	Labtician Ophthalmics, Inc.	1999-01-08	86	0
K971242	BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)	Ipax, Inc.	1997-12-17	259	0
K971245	BLINK EXTERNAL EYELID WEIGHT	Ipax, Inc.	1997-06-20	78	0
K940974	EYECLOSE EXTERNAL EYELID WEIGHTS	Meddev Corp.	1994-06-08	97	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