# Huxley Medical

- Location (FDA's records): Atlanta, GA
- FDA decisions: 4 (2024–2025): 4 510(k) clearances
- Product codes: MNR (4)
- 510(k) review time since 2016: median 145 days, against 165 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 3 (2 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
- Sibel, Inc.: 1 (https://510kreport.com/company/sibel)
- iRhythm Technologies, Inc.: 1 (https://510kreport.com/company/irhythm-technologies)

## Firms that cite its devices most
- Vivaquant, Inc. Dba Rhythm Express: 1 (https://510kreport.com/company/vivaquant-dba-rhythm-express)

## Its most-cited devices
- K244027: Sansa Hsat (2025), cited by 2
- K240285: Huxley SANSA Home Sleep Apnea Test (1000-00) (2024), cited by 1

## Recent decisions
- K252497: Sansa Hsat (Dec 10, 2025)
- K250882: Sansa Hsat (Oct 29, 2025)
- K244027: Sansa Hsat (Jan 28, 2025)
- K240285: Huxley SANSA Home Sleep Apnea Test (1000-00) (Jul 15, 2024)

Source page: https://510kreport.com/company/huxley-medical