Atlas FDA

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

Revmedx, Inc. · Predicate Candidate Screening

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

107 daysmedian FDA review time
428 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253290XSTAT P15Revmedx, Inc.2025-11-12440
K210676XSTAT 30 PouchRevmedx, Inc.2021-08-271750
K180051XSTAT 30, 1-PackRevmedx, Inc.2018-05-181300
K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT Revmedx, Inc.2017-05-01880
K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc.2016-07-281070
K152624XSTAT 30, 3-PACK, XSTAT 30, 1-PACKRevmedx, Inc.2015-12-07840
DEN130016XSTATRevmedx, Inc.2014-04-034280

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