Company ยท GB
Huntleigh Healthcare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2025. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 11 |
| JOW | Sleeve, Limb, Compressible | 7 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 |
| DQA | Oximeter | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 2025 | K250777 | Sonicaid Team3 Huntleigh Healthcare , Ltd., GB | HGM |
| Feb 3, 2025 | K241368 | Sonicaid Team3 Huntleigh Healthcare , Ltd., GB | HGM |
| Sep 3, 2021 | K211200 | WoundExpress Huntleigh Healthcare , Ltd., GB | JOW |
| Feb 19, 2021 | K201425 | Disposable Intraoperative Probe (DIOP8) Huntleigh Healthcare Limited, GB | ITX |
| Jun 24, 2020 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum Huntleigh Healthcare Limited, GB | HGM |
| Sep 6, 2019 | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes Huntleigh Healthcare , Ltd., GB | DPW |
| Apr 4, 2016 | K152228 | Hydroven 12, Hydroven 12 Garments Huntleigh Healthcare , Ltd., GB | JOW |
| Feb 7, 2014 | K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM Huntleigh Healthcare Limited, GB | HGM |
| Jan 3, 2013 | K121108 | DOPPLEX ABILITY Huntleigh Healthcare, GB | JOM |
| Jul 15, 2009 | K090285 | SONICAID FM820 AND FM830 ENCORE Huntleigh Healthcare , Ltd., GB | HGM |
| Oct 1, 2008 | K081572 | SMARTSIGNS MINPULSE Huntleigh Healthcare , Ltd., GB | DQA |
| Mar 23, 2006 | K060230 | DOPPLEX CENTRALE Huntleigh Healthcare , Ltd., GB | HGM |
| Dec 22, 2005 | K053369 | MEDILOG DARWIN HOLTER ANALYSIS Huntleigh Healthcare, GB | DQK |
| Nov 18, 2004 | K032315 | IOP8 INTRA OPERATIVE PROBE Huntleigh Healthcare, Inc., GB | ITX |
| Sep 19, 2002 | K022786 | DVT60 Huntleigh Healthcare, Inc. | JOW |
| Mar 26, 2002 | K010744 | FLOWTRON UNIVERSAL, MODEL AC600 Huntleigh Healthcare, Inc. | JOW |
| Sep 21, 2001 | K012008 | STS RANGE , MODELS STS20,STS30,STS40 Huntleigh Healthcare, Inc. | JOW |
| May 2, 2001 | K002186 | VASCULAR ASSIST Huntleigh Healthcare, Inc. | DPW |
| Apr 25, 2001 | K010894 | BABY DOPPLEX 3002 (BD3002) Huntleigh Healthcare, Inc., GB | HGM |
| Apr 25, 2001 | K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) Huntleigh Healthcare, Inc., GB | HGM |
| Sep 19, 2000 | K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 Huntleigh Healthcare, Inc. | HGM |
| Jan 24, 2000 | K990569 | BABY DOPPLEX 4000, MODEL BD 4000 Huntleigh Healthcare, Inc. | HGM |
| Jan 12, 1999 | K984307 | MODIFICATION OF: RHEO DOPPLEX II Huntleigh Healthcare, Inc. | IYN |
| Jan 26, 1998 | K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 Huntleigh Healthcare, Inc. | JOW |
| Sep 12, 1997 | K963711 | BABY DOPPLEX (3000) Huntleigh Healthcare, Inc. | HGM |
| Jun 24, 1994 | K930200 | MULTI DOPPLEX II / FETAL DOPPLEX II Huntleigh Healthcare, Inc. | KNG |
| May 7, 1993 | K925717 | CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE Huntleigh Healthcare, Inc. | JOW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2022 | Huntleigh Healthcare Ltd. HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 Terminated |
ITX | K201425 |