Cleared Traditional

K132650 - SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM

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
4d slower than avg
Panel avg: 161d · 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 177
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K132650.
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K140535 · Philips Medizin Systeme Boblingen GmbH · Nov 2014
FM-3000 FETAL MONITOR
K141194 · Advanced Instrumentations, Inc. · Nov 2014
FETAL MONITORS
K131941 · Guangdong Biolight Meditech Co., Ltd. · May 2014
SENSE-4BABY SYSTEM
K132918 · Sense4baby , Inc. · Nov 2013
SUNRAY FETAL MONITOR
K123335 · Sunray Medical Apparatus Co., Ltd. · Mar 2013
CERNER FETALINK+(VERSION1.0)
K121758 · Cerner Corp. · Oct 2012