510(k) Report

FDA applicant

Biotricity

Redwood City, CA5 decisions2016–20220 recalls

FDA records 5 decisions for Biotricity (Redwood City, CA) from 2016 to 2022: 5 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSH (Recorder, Magnetic Tape, Medical). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 244 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biotricity, Inc.”.

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 Biotricity’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2016: 12017: 12020: 12022: 2
2016high 2 (2022) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

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Which product codes does it file in?

  • MWJElectrocardiograph, Ambulatory (Without Analysis)2decisions
  • DSHRecorder, Magnetic Tape, Medical2decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 244 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K211709BiotresBiotricity · 20222cite it
  • K162571Bioflux SoftwareBiotricity, Inc. · 20161cites it
  • K172311BioFlux DeviceBiotricity, Inc. · 20171cites it

What has FDA decided for it lately?

  • K222017BiotresBiotricity · 2022
  • K211709BiotresBiotricity · 2022
  • K201040Bioflux Software IIBiotricity · 2020
  • K172311BioFlux DeviceBiotricity, Inc. · 2017
  • K162571Bioflux SoftwareBiotricity, Inc. · 2016

All 3 as Biotricity →All 2 as Biotricity, Inc. →