Huntleigh Healthcare Ltd.
CARDIFF, SOUTH GLAMORGAN Cardiff, GB
HUNTLEIGH HEALTHCARE LTD. appears in FDA device records in CARDIFF, SOUTH GLAMORGAN Cardiff, GB. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Huntleigh Healthcare Ltd. between 1993 and 2025. The busiest year on record is 2001, with 4. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250777 | Sonicaid Team3 | HGM | Substantially Equivalent | |
| K241368 | Sonicaid Team3 | HGM | Substantially Equivalent | |
| K211200 | WoundExpress | JOW | Substantially Equivalent | |
| K201425 | Disposable Intraoperative Probe (DIOP8) | ITX | Substantially Equivalent | |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | HGM | Substantially Equivalent | |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | DPW | Substantially Equivalent | |
| K152228 | Hydroven 12, Hydroven 12 Garments | JOW | Substantially Equivalent | |
| K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM | HGM | Substantially Equivalent | |
| K121108 | DOPPLEX ABILITY | JOM | Substantially Equivalent | |
| K090285 | SONICAID FM820 AND FM830 ENCORE | HGM | Substantially Equivalent | |
| K081572 | SMARTSIGNS MINPULSE | DQA | Substantially Equivalent | |
| K060230 | DOPPLEX CENTRALE | HGM | Substantially Equivalent | |
| K053369 | MEDILOG DARWIN HOLTER ANALYSIS | DQK | Substantially Equivalent | |
| K032315 | IOP8 INTRA OPERATIVE PROBE | ITX | Substantially Equivalent | |
| K022786 | DVT60 | JOW | Substantially Equivalent | |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | JOW | Substantially Equivalent | |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | JOW | Substantially Equivalent | |
| K002186 | VASCULAR ASSIST | DPW | Substantially Equivalent | |
| K010894 | BABY DOPPLEX 3002 (BD3002) | HGM | Substantially Equivalent | |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | HGM | Substantially Equivalent | |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | HGM | Substantially Equivalent | |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | HGM | Substantially Equivalent | |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | IYN | Substantially Equivalent | |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | JOW | Substantially Equivalent | |
| K963711 | BABY DOPPLEX (3000) | HGM | Substantially Equivalent | |
| K930200 | MULTI DOPPLEX II / FETAL DOPPLEX II | KNG | Substantially Equivalent | |
| K925717 | CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE | JOW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000589001 | 1000589001 | HUNTLEIGH HEALTHCARE LTD. | DIAGNOSTIC PRODUCT DIVISION, CARDIFF, SOUTH GLAMORGAN CF24 5HN GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- DQKComputer, Diagnostic, Programmable
- DPWFlowmeter, Blood, Cardiovascular
- KNGMonitor, Ultrasonic, Fetal
- JAFMonitor, Ultrasonic, Nonfetal
- DQAOximeter
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- JOWSleeve, Limb, Compressible
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0960-2022 | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 | Faceplate may become detached from the probe body. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain