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

HMF — Predicate Candidate Screening

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

53 daysmedian FDA review time

194 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K935952	ROTA SYSTEM 5000	Rota Systems Medfurniture, Inc.	1994-04-19	127
K935945	ROTA DATAMATE I	Rota Systems,Inc.	1994-04-19	127
K931839	ROTA SYSTEM XL	Rota Systems Medfurniture, Inc.	1993-11-22	223
K930440	MARCO INTERNATIONAL STAND	Marco Ophthalmic, Inc.	1993-07-06	161
K924771	BURTON OPHTHALMIC STAND - MODEL XL3200	R.H. Burton Co.	1993-04-05	194
K924780	BURTON OPHTHALMIC EXAM UNIT - MODEL 2201	R.H. Burton Co.	1993-04-05	194
K913961	OPHTHALMIC STAND	Luneau Ophtalmologie SA	1991-12-04	90
K853358	RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM	Dentsply Intl.	1985-10-04	53
K844362	OPHTHALMIC CHAIR	Luneau Laboratories	1984-12-11	28
K844363	OPHTHALMIC STAND	Luneau Laboratories	1984-12-05	22
K832073	ELECTRIC INSTRUMENT TABLE	CooperVision, Inc.	1983-08-12	45
K812544	RELIANCE OPHTHALMIC INSTRUMENT CONTROL	F. & F. Koenigkramer	1981-09-21	17
K803195	SYSTEM 1 INSTRUMENT STAND	Surgical Mechanical Research, Inc.	1981-02-04	50
K791104	B & L OPHTHALMIC INSTRUMENT STAND	Bausch & Lomb, Inc.	1979-07-24	41
K791105	B & L OPHTHALMIC CHAIR	Bausch & Lomb, Inc.	1979-07-24	41

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