# Oxehealth Limited

- Location (FDA's records): Oxford, GB
- FDA decisions: 6 (2021–2026): 5 510(k) clearances and 1 De Novo grant
- Product codes: QME (5), LEL (1)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sleep Performance D.B.A. Fatigue Science: 1 (https://510kreport.com/company/sleep-performance-dba-fatigue-science)

## Firms that cite its devices most
- Mindset Medical, Inc.: 2 (https://510kreport.com/company/mindset-medical)
- PanopticAI technologies Limited: 2 (https://510kreport.com/company/panopticai-technologies)
- Faceheart Corp.: 1 (https://510kreport.com/company/faceheart)
- Presage Security, Inc. d/b/a Presage Technologies, Inc.: 1 (https://510kreport.com/company/presage-security-d-b-a-presage-technologies)

## Its most-cited devices
- K211906: Vital Signs (2021), cited by 9
- DEN200019: Oxehealth Vital Signs (2021), cited by 1

## Recent decisions
- K251200: Vital Signs (Feb 2, 2026)
- K243687: Vital Signs (Aug 27, 2025)
- K233618: Oxevision Sleep Device (Apr 3, 2024)
- K220899: Oxehealth Vital Signs (Apr 29, 2022)
- K211906: Vital Signs (Jul 20, 2021)
- DEN200019: Oxehealth Vital Signs (Mar 26, 2021)

Source page: https://510kreport.com/company/oxehealth