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510(k) K250777

Sonicaid Team3 by Huntleigh Healthcare , Ltd. — Product Code HGM

K250777 is an FDA 510(k) premarket notification submitted by Huntleigh Healthcare , Ltd. for the device "Sonicaid Team3". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Huntleigh Healthcare , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
March 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type

Other clearances by Huntleigh Healthcare , Ltd.

  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K211200 — WoundExpress (September 3, 2021)
  • K183574 — SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (September 6, 2019)
  • K152228 — Hydroven 12, Hydroven 12 Garments (April 4, 2016)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)
  • K090285 — SONICAID FM820 AND FM830 ENCORE (July 15, 2009)
  • K081572 — SMARTSIGNS MINPULSE (October 1, 2008)
  • K060230 — DOPPLEX CENTRALE (March 23, 2006)
  • K053369 — MEDILOG DARWIN HOLTER ANALYSIS (December 22, 2005)
  • K032315 — IOP8 INTRA OPERATIVE PROBE (November 18, 2004)

Other clearances for product code HGM

  • K253021 — ANNE Maternal (February 26, 2026)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K241009 — PeriCALM Patterns 3.0 (January 10, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231964 — Novii+ Wireless Patch System (December 8, 2023)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)
  • K173941 — IntelliSpace Perinatal Rev.K.00 (September 10, 2018)

FDA data resources