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Data / Medical devices / United Kingdom / Huntleigh Healthcare Ltd.

Huntleigh Healthcare Ltd.: FDA-registered device maker in Cardiff, South Glamorgan, United Kingdom, 15 510(k) clearances

Huntleigh Healthcare Ltd. is registered with the FDA (registration 1000589001) in Cardiff, South Glamorgan, United Kingdom. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 19, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Huntleigh Healthcare Ltd.
FDA registration number
1000589001
Address
Diagnostic Product Division 35 Portmanmoor Road, Cardiff, South Glamorgan, United Kingdom, CF24 5HN
Owner or operator
ARJOHUNTLEIGH AB (8010077)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
December 5, 2007
Registered through
2026
Brand names listed
Centrale, D930, DMX HANDHELD DOPPLER AND PROBES, DOPPLEX ABILITY, Disposable Intraoperative Probe (DIOP8), Dopplex, FD3, OBSTETRIC DOPPLER, FETAL DOPPLEX, FD1 and more

Devices it lists

DeviceProduct codeClassRoleSource
Blood Pressure CuffDXQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Flowmeter, Blood, CardiovascularDPW2Complaint file establishment, Manufactureraccessdata.fda.gov
Monitor, Ultrasonic, FetalKNG2Complaint file establishment, Manufactureraccessdata.fda.gov
Monitor, Ultrasonic, NonfetalJAF2Complaint file establishment, Manufactureraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Manufactureraccessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or HydraulicJOM2Complaint file establishment, Manufactureraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Complaint file establishment, Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Complaint file establishment, Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, ObstetricHGL2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 19, 2025K250777Sonicaid Team3HGMSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
February 3, 2025K241368Sonicaid Team3HGMSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
September 3, 2021K211200WoundExpressJOWSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
February 19, 2021K201425Disposable Intraoperative Probe (DIOP8)ITXSubstantially EquivalentHuntleigh Healthcare Limitedaccessdata.fda.gov
June 24, 2020K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGMSubstantially EquivalentHuntleigh Healthcare Limitedaccessdata.fda.gov
September 6, 2019K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPWSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
April 4, 2016K152228Hydroven 12, Hydroven 12 GarmentsJOWSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
February 7, 2014K132650SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEMHGMSubstantially EquivalentHuntleigh Healthcare Limitedaccessdata.fda.gov
January 3, 2013K121108DOPPLEX ABILITYJOMSubstantially EquivalentHuntleigh Healthcareaccessdata.fda.gov
October 1, 2008K081572SMARTSIGNS MINPULSEDQASubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
March 23, 2006K060230DOPPLEX CENTRALEHGMSubstantially EquivalentHuntleigh Healthcare , Ltd.accessdata.fda.gov
June 24, 1994K930200MULTI DOPPLEX II / FETAL DOPPLEX IIKNGSubstantially EquivalentHuntleigh Healthcare, Inc.accessdata.fda.gov
June 28, 1993K924516OP3/VP4HGLSubstantially EquivalentHuntleigh Technology, Inc.accessdata.fda.gov
May 28, 1991K910188FLOWPLUS AC330 PUMP GARMENTSJOWSubstantially EquivalentHuntleigh Technology, Inc.accessdata.fda.gov
April 25, 1990K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140KNGSubstantially EquivalentHuntleigh Technology, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 11, 202289580Class IITerminatedHUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8Faceplate may become detached from the probe body.accessdata.fda.gov

Compare with other makers

Updated September 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.