510(k) Report

FDA applicant

Vitalconnect, Inc.

San Jose, CA10 decisions2014–20251 recall

FDA records 10 decisions for Vitalconnect, Inc. (San Jose, CA) from 2014 to 2025: 10 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Vitalconnect, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 22015: 12017: 22019: 22020: 22025: 1
2014high 2 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2014high 1 (2020) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Vitalconnect, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vitalconnect, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency9decisions
  • DQKComputer, Diagnostic, Programmable1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 20159cite it
  • K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software…Vitalconnect, Inc. · 20145cite it
  • K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc. · 20192cite it
  • K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc. · 20172cite it
  • K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc. · 20141cites it
  • K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20…Vitalconnect, Inc. · 20201cites it

What has FDA decided for it lately?

  • K242129VitalRhythmVitalconnect, Inc. · 2025
  • K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)Vitalconnect, Inc. · 20201 recall
  • K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20…Vitalconnect, Inc. · 2020
  • K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc. · 2019
  • K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc. · 2019
  • K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc. · 2017
  • K170973VitalWatch Software User InterfaceVitalconnect, Inc. · 2017
  • K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015

All 10 as Vitalconnect, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193343VistaSolution, physiological signal transmitter. A software graphical user interface for…May 21, 2020Class II