Atlas FDA

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

Vermont Medical, Inc. · Predicate Candidate Screening

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

161 daysmedian FDA review time
435 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030073VERMED A10021 RESTING EKG TAB ELECTRODEVermont Medical, Inc.2003-03-28790
K021537MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005Vermont Medical, Inc.2003-03-032970
K010638NEUROPLUS, MODEL A10040, A10041, A10042, A10043Vermont Medical, Inc.2001-05-03590
K921498VER MED A10011 PNS DUAL ELEMENT ELECTRODEVermont Medical, Inc.1993-06-094350
K915831THERMAL PROBE COVERVermont Medical, Inc.1992-06-081610
K911687VER-MED A10020 RESTING EKG ELECTRODEVermont Medical, Inc.1991-10-101770
K910139VER-MED A10014 RESTING EKG ELECTRODE & A10021Vermont Medical, Inc.1991-08-152130
K905489VER-MED A10017 UNIVERSAL ELECTRODEVermont Medical, Inc.1991-03-211040
K781430PREGELLED DISPOSABLE E.K.G. ELECTRODEVermont Medical, Inc.1978-10-31710

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