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

KYE — Predicate Candidate Screening

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

42 daysmedian FDA review time

183 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K872567	SOFT CONTACT LENS REMOVER	Magnivision, Inc.	1987-08-10	42
K872591	HARD CONTACT LENS REMOVER. ITEM #289	Magnivision, Inc.	1987-08-04	34
K871130	CONTACT LENS TWEEZERS	S. M. C. Medi-Tech Corp.	1987-05-12	53
K870072	SUMMIT OPTICS CONTACT LENS REMOVER	Dayton Mfg. Co.	1987-02-12	35
K850984	MARLIN SOFT LENS HANDLER	Marlin Industries	1985-09-10	183
K850983	MARLIN SOFT LENS TWEEZER	Marlin Industries	1985-09-10	183
K830738	LENSERT CONTACT LENS CLEANING & INSERT	Jermyn Specialties of California	1983-06-10	94
K830496	DMV ANGLER	Dmv Contact Lens Co.	1983-03-09	21
K782140	REMOVER, SOFT-SERT CONTACT LENS	Mcmurray and Pendergost	1979-02-12	47
K780931	SOFT LENS INSERTER	Soft-Sert	1978-06-28	22
K780664	SOFT LENS REMOVER/INSERTER/MANIPULATOR	Dmv Contact Lens Co.	1978-05-17	27
K780663	CONTACT LENS REMOVER AND INSERTER	Dmv Contact Lens Co.	1978-05-17	27

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