510(k) Report

FDA applicant

Oxehealth Limited

Oxford, GB6 decisions2021–20260 recalls

FDA records 6 decisions for Oxehealth Limited (Oxford, GB) from 2021 to 2026: 5 510(k) clearances and 1 De Novo grant. Most are in product codes QME (Software For Optical Camera-Based Measurement…) and LEL (Device, Sleep Assessment). Its devices cite 5 predicates, 4 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2021: 22022: 12024: 12025: 12026 (partial year): 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Oxehealth Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate…5decisions
  • LELDevice, Sleep Assessment1decision

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 4 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.

  • K211906Vital SignsOxehealth Limited · 20219cite it
  • DEN200019Oxehealth Vital SignsOxehealth Limited · 20211cites it

What has FDA decided for it lately?

  • K251200Vital SignsOxehealth Limited · 2026
  • K243687Vital SignsOxehealth Limited · 2025
  • K233618Oxevision Sleep DeviceOxehealth Limited · 2024
  • K220899Oxehealth Vital SignsOxehealth Limited · 2022
  • K211906Vital SignsOxehealth Limited · 2021
  • DEN200019Oxehealth Vital SignsOxehealth Limited · 2021

All 6 as Oxehealth Limited →