510(k) Report

FDA applicant

VivaLNK, Inc.

Santa Clara, CA3 decisions2017–20200 recalls

FDA records 3 decisions for VivaLNK, Inc. (Santa Clara, CA) from 2017 to 2020: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DRG (Transmitters And Receivers, Physiological…). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2020

2017: 12018: 12020: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — VivaLNK, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • FLLContinuous Measurement Thermometer2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 174 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 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.

  • K181013Fever ScoutVivaLNK, Inc. · 20186cite it
  • K162137Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 20173cite it

What has FDA decided for it lately?

  • K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc. · 2020
  • K181013Fever ScoutVivaLNK, Inc. · 2018
  • K162137Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017

All 3 as VivaLNK, Inc. →