Atlas FDA

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

Surgipath — Predicate Candidate Screening

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

25 daysmedian FDA review time
30 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K820027MODIFIED EA 50Surgipath1982-02-04300
K81294010% NEUTRAL BUFFERED FORMALIN CONCENTSurgipath1981-12-10510
K812086EA 65Surgipath1981-08-13220
K812087EA 50Surgipath1981-08-13220
K811826EOSIN YSurgipath1981-07-10110
K811825ORANGE G-6Surgipath1981-07-10110
K810836DECALCIFIER IISurgipath1981-04-23280
K810758GILL'S HEMATOXYLIN #1Surgipath1981-04-14250
K810760GILL'S HEMATOXYLIN #3Surgipath1981-04-14250
K810733HARRIS HEMATOXYLINSurgipath1981-04-14270
K810759GILL'S HEMATOXYLIN #2Surgipath1981-04-14250
K810323ACRYTOL, MOUNTING MEDIUMSurgipath1981-03-06280

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