Cleared Traditional

K132650 - SONICAID FREEDOM WIRELESS FETAL MONITOR...

K132650 is an FDA 510(k) clearance for SONICAID FREEDOM WIRELESS FETAL MONITOR..., manufactured by Huntleigh Healthcare Limited. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K132650 · Huntleigh Healthcare Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
165d
Days
Class 2
Risk

K132650 is an FDA 510(k) clearance for the SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Healthcare Limited (Cardiff, GB). The FDA issued a Cleared decision on February 7, 2014 after a review of 165 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Huntleigh Healthcare Limited devices

FDA 510(k) Submission Details - K132650

510(k) Number K132650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date February 07, 2014
Days to Decision 165 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 160d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 102
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K132650.
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · Edan Instruments, Inc. · Jul 2015
CENTRAL MONITORING SYSTEM
K143695 · Edan Instruments, Inc. · Mar 2015
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K111083 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2011
FETAL MONITORS, MODELS F2 AND F3
K102140 · Edan Instruments, Inc. · Jan 2011
CENTRAL MONITORING SYSTEM
K100358 · Edan Instruments, Inc. · Jan 2011