Company profile

Oxehealth Limited

Oxehealth Limited has 6 AI-enabled medical devices on the FDA list. The first decision was on March 26, 2021 and the most recent on February 2, 2026 (Vital Signs). Its most common review panel is Cardiovascular (5 devices).

6AI devices

2021First decision

2026Latest decision

2Specialties

Per year

20212022202420252026

Oxehealth Limited AI devices per year: 2021 2, 2022 1, 2024 1, 2025 1, 2026 1

By specialty

Cardiovascular5
Neurology1

Related guides

Top cardiovascular devices

Timeline

February 2, 2026 · 510(k) K251200Vital Signs · Cardiovascular · QME
August 27, 2025 · 510(k) K243687Vital Signs · Cardiovascular · QME
April 3, 2024 · 510(k) K233618Oxevision Sleep Device · Neurology · LEL
April 29, 2022 · 510(k) K220899Oxehealth Vital Signs · Cardiovascular · QME
July 20, 2021 · 510(k) K211906Vital Signs · Cardiovascular · QME
March 26, 2021 · De Novo DEN200019Oxehealth Vital Signs · Cardiovascular · QME