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

HLR — Predicate Candidate Screening

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

33 daysmedian FDA review time

108 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K901553	SURG-K SURGICAL KERATOMETER	The Sanborn Co.	1990-07-20	108
K882902	QRK 100, QUALITATIVE RING KERATOSCOPE	Technitex, Inc.	1988-08-04	23
K882618	JEDMED/POLACK KERATOSCOPE HS/SL	Gamut Ent.	1988-07-13	19
K864639	REUSABLE SURGICAL KERATOSCOPE	Jedmed Instrument Co.	1986-12-29	33
K854054	PLACIDO DISC	Cutler Medical Instruments	1985-12-27	85
K830008	KARICKHOFF KERATOSCOPE	Surgidev Corp.	1983-01-26	23
K821080	HAND KERATOSCOPE	Medical Equipment Designs, Inc.	1982-05-24	35

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