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

HOS — Predicate Candidate Screening

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

79 daysmedian FDA review time

273 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K936200	WIRELESS CHART PROJECTOR,HCP-W 721	Canon USA, Inc.	1994-09-28	273
K930443	MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE	Marco Ophthalmic, Inc.	1993-07-06	161
K924784	BURTON PROJECTOR HEAD - MODEL 6000-H	R.H. Burton Co.	1993-04-05	194
K921214	OPHTHALMIC PROJECTOR	Luneau Ophtalmologie SA	1992-06-11	90
K890992	WOODLYN OPHTHALMIC PROJECTOR	Woodlyn, Inc.	1989-05-17	79
K862519	BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR	Bausch & Lomb, Inc.	1986-07-23	22
K812706	MILLER/NADLER GLARE TESTER	Mosebach Electric & Supply	1981-11-16	53
K811180	ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ	American Optical Corp.	1981-05-15	17
K781658	PROJECTOR, ACCU-CHART ACUITY	Bausch & Lomb, Inc.	1978-10-17	19

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