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

HRJ — Predicate Candidate Screening

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

63 daysmedian FDA review time

161 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K930447	MARCO H AND TS-1 INSTRUMENT TABLES	Marco Ophthalmic, Inc.	1993-07-06	161
K922242	910T MONTORIZED INSTRUMENT TABLE	R.H. Burton Co.	1992-09-30	140
K912134	TBD, LENS MEASURING DEVICE	Alcon Laboratories	1991-07-25	72
K853744	TECHNA VISION, INC.ELECTRIC TABLE	Techna Vision	1985-10-17	41
K853359	RELIANCE 1379	Dentsply Intl.	1985-09-24	43
K841760	WOODLYN CLASSIC INSTRUMENT STAND	Woodlyn, Inc.	1984-06-19	53
K833820	MACHEMER/TANO ROTATING	Optical Micro Systems, Inc.	1984-01-04	63

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