Atlas FDA

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

Vitalconnect, Inc. — Predicate Candidate Screening

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

129 daysmedian FDA review time
328 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242129VitalRhythmVitalconnect, Inc.2025-04-172690
K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day EvaluVitalconnect, Inc.2020-04-201391
K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - Vitalconnect, Inc.2020-02-061290
K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - Vitalconnect, Inc.2019-06-07590
K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.2019-03-071220
K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.2017-11-023280
K170973VitalWatch Software User InterfaceVitalconnect, Inc.2017-06-02600
K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.2015-12-061250
K141167VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, REVitalconnect, Inc.2014-07-29840
K132447VITALCONNECT PLATFORM BY VITAL CONNECT INC.Vitalconnect, Inc.2014-04-032400

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