510(k) Report

FDA applicant

Trividia Health, Inc.

Fort Lauderdale, FL3 decisions2016–20261 recall

FDA records 3 decisions for Trividia Health, Inc. (Fort Lauderdale, FL) from 2016 to 2026: 3 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and QRL (Multiple Use Blood Lancet For Single Patient…). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Trividia Health”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2022

2016: 12022: 12026 (partial year): 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1, 1 Class I
2016high 1 (2026) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Trividia Health, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trividia Health, 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?

  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions
  • QRLMultiple Use Blood Lancet For Single Patient Use Only1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 189 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 190 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026
  • K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health · 2022
  • K143548TRUE METRIX GO Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 20161 Class I recall

All 2 as Trividia Health, Inc. →The one decision as Trividia Health →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143548Owner's Booklets and Instructions for Use that are used with the following blood glucose…Feb 6, 2026Class I