Sonicaid Team3

FDA 510(k) K241368 · Huntleigh Healthcare , Ltd.

Substantially Equivalent

510(k) numberK241368

Submission

Device name
Sonicaid Team3
Applicant
Huntleigh Healthcare , Ltd.
Cardiff, GB
Received
May 14, 2024
Decision date
February 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
HGM – System, Monitoring, Perinatal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2740
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGM

510(k)DeviceApplicantDecision
K254036Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda, Inc.08/10/2026SE
K253021ANNE MaternalHGM · Traditional Sibel Health, Inc.02/26/2026SE
K250777Sonicaid Team3HGM · Traditional Huntleigh Healthcare , Ltd.09/19/2025SE
K241882Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional Edan Instruments, Inc.08/27/2025SE
K241009PeriCALM Patterns 3.0HGM · Traditional Perigen, Inc.01/10/2025SE
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional Philips Medizin Systeme Boeblingen GmbH07/02/2024SE
K231964Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda12/08/2023SE
K222327Bloomlife MFM-ProHGM · Traditional Bloom Technologies NV02/13/2023SE
K220732Mural Perinatal SurveillanceHGM · Traditional Ge Medical Systems Information Technologies, Inc.06/23/2022SE
K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional Huntleigh Healthcare Limited06/24/2020SE

More from Huntleigh Healthcare Limited

510(k)DeviceDecision
K250777Sonicaid Team3HGM · Traditional 09/19/2025SE
K211200WoundExpressJOW · Traditional 09/03/2021SE
K201425Disposable Intraoperative Probe (DIOP8)ITX · Traditional 02/19/2021SE
K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional 06/24/2020SE
K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPW · Abbreviated 09/06/2019SE
K152228Hydroven 12, Hydroven 12 GarmentsJOW · Traditional 04/04/2016SE
K132650Sonicaid Freedom Wireless Fetal Monitoring SystemHGM · Traditional 02/07/2014SE
K121108Dopplex AbilityJOM · Traditional 01/03/2013SE
K090285Sonicaid FM820 and FM830 EncoreHGM · Traditional 07/15/2009SE
K081572Smartsigns MinpulseDQA · Traditional 10/01/2008SE

Questions and answers

When was Sonicaid Team3 cleared by the FDA?

Sonicaid Team3 (K241368) received a 510(k) decision of Substantially Equivalent on February 3, 2025, 265 days after the submission was received.

What is the product code of K241368?

The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.