# Huntleigh Healthcare, Inc.

- Location (FDA's records): Cardiff, GB
- FDA decisions: 27 (1993–2025): 27 510(k) clearances
- Names in FDA's records: Huntleigh Healthcare, Inc. (14); Huntleigh Healthcare , Ltd. (8); Huntleigh Healthcare Limited (3); Huntleigh Healthcare (2)
- Product codes: HGM (11), JOW (7), ITX (2), DPW (2), KNG (1), DQK (1), IYN (1), JOM (1), DQA (1)
- 510(k) review time since 2016: median 250 days, against 154 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 32 (9 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hewlett-Packard Co.: 4 (https://510kreport.com/company/hewlett-packard)
- Oxford Instruments, Plc.: 2 (https://510kreport.com/company/oxford-instruments)
- Medical Compression Systems (Dbn), Ltd.: 1 (https://510kreport.com/company/medical-compression-systems-dbn)
- Innovamed Health, LLC: 1 (https://510kreport.com/company/innovamed-health)
- Mego Afek: 1 (https://510kreport.com/company/mego-afek)
- Hne Healthcare, Inc.: 1 (https://510kreport.com/company/hne-healthcare)
- Remote Diagnostic Technologies, Ltd.: 1 (https://510kreport.com/company/remote-diagnostic-technologies)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Arjohuntleigh Polska SP Z.O.O.: 3 (https://510kreport.com/company/arjohuntleigh-polska-sp-zoo)
- Hygia Health Services, Inc.: 2 (https://510kreport.com/company/hygia-health-services)
- Devon Medical, Inc.: 2 (https://510kreport.com/company/devon-medical)
- Suretek Medical: 2 (https://510kreport.com/company/suretek-medical)
- Mego Afek: 1 (https://510kreport.com/company/mego-afek)
- Summit Doppler Systems, Inc.: 1 (https://510kreport.com/company/summit-doppler-systems)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Koven Technology, Inc.: 1 (https://510kreport.com/company/koven-technology)

## Its most-cited devices
- K010744: Flowtron Universal, Model AC600 (2002), cited by 7
- K930200: Multi Dopplex II / Fetal Dopplex II (1994), cited by 5
- K965153: Huntleigh FP5000 System Model FP5000 (1998), cited by 2
- K010889: Baby Dopplex 3000 MK 2 (BD3000) (2001), cited by 2
- K925717: Calf Garment DVT10(S) Compressible Limb Sleeve (1993), cited by 2
- K022786: DVT60 (2002), cited by 2

## Recent decisions
- K250777: Sonicaid Team3 (Sep 19, 2025)
- K241368: Sonicaid Team3 (Feb 3, 2025)
- K211200: WoundExpress (Sep 3, 2021)
- K201425: Disposable Intraoperative Probe (DIOP8) (Feb 19, 2021)
- K200975: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (Jun 24, 2020)
- K183574: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (Sep 6, 2019)
- K152228: Hydroven 12, Hydroven 12 Garments (Apr 4, 2016)
- K132650: Sonicaid Freedom Wireless Fetal Monitoring System (Feb 7, 2014)

Source page: https://510kreport.com/company/huntleigh-healthcare