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

Accutome, Inc. — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
252 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K1525734SightAccutome, Inc.2015-11-25770
K132549ACCUTIP COVERAccutome, Inc.2014-04-232520
K123349A-SCAN PLUS CONNECTAccutome, Inc.2013-01-29900
K103471UBM PLUSAccutome, Inc.2011-03-141100
K050552PACHPEN PACHYMETER, MODEL 24-5100Accutome, Inc.2005-03-28250
K032956ACCUSONIC A-SCAN MODEL, 24-4000Accutome, Inc.2003-10-10180
K820050KREMER BLADE GAUGEAccutome, Inc.1982-02-24470
K810660KREMER CORNEOMETER ULTRASONIC PACHOMETERAccutome, Inc.1981-08-211630

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