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

HLM — Predicate Candidate Screening

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

146 daysmedian FDA review time

209 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K944022	LENSCHEK	Leica, Inc.	1994-11-17	92
K940997	AL-3300	Hoya Corp. USA	1994-09-29	209
K936199	AUTOMATIC LENSOMETER	Canon USA, Inc.	1994-09-28	273
K930441	MARCO STANDARD LENSMETERS 101,201	Marco Ophthalmic, Inc.	1993-07-06	161
K930445	MARCO LM-770 DIGITAL PROJECTION LENSMETER	Marco Ophthalmic, Inc.	1993-06-21	146
K924776	BURTON LENSMETER - MODEL 2021	R.H. Burton Co.	1993-04-05	194
K924785	BURTON RADIUSGAUGE - MODEL 2030	R.H. Burton Co.	1993-04-05	194
K924788	BURTON LENSMETER	R.H. Burton Co.	1993-04-05	194
K920861	WOODLYN CLASSIC LENSMETER	Woodlyn, Inc.	1992-07-30	156
K884188	NIDEK LM-870 AUTOMATIC LENSMETER	Nidek, Inc.	1988-11-23	49
K862518	BAUSCH & LOMB VERTOMETER V-5	Bausch & Lomb, Inc.	1986-08-11	41
K861064	LM-850 AUTOMATIC LENSMETER	Nidek, Inc.	1986-04-15	26
K801767	DIMENSION I REFRACTION SYSTEM	Smr	1980-09-16	50
K791521	VERI-VU LENSOMETER	Intermedics, Inc.	1979-10-30	81
K782096	INSTRUMENTS, OVERREFRACTION SYSTEM	Zeiss Humphrey System	1979-01-26	39
K781440	LENSOMETER MODEL 11	Rodenstock Instrument Corp.	1978-09-07	20

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