Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

HOE · Predicate Candidate Screening

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

35 daysmedian FDA review time

97 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K881094	KOI(TM) BLADE GAUGE, MODEL KOI-132	CooperVision, Inc.	1988-04-01	17
K813315	CALIPER-OPTHALMIC	Design Research Assoc., Inc.	1982-03-01	97
K820050	KREMER BLADE GAUGE	Accutome, Inc.	1982-02-24	47
K812011	BLADE GAUGE	Koi, Inc.	1981-07-28	11
K801937	BLEPHAROMETER	Aztec Medical Products, Inc.	1980-09-16	35
K792383	KELMAN DIPSTICK	V. Mueller O.V. Baxter Healthcare Corp.	1979-12-11	15
K781715	RULER, WECK SCOTT	Edward Weck, Inc.	1978-12-04	60

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