Cleared Traditional

K220732 - Mural Perinatal Surveillance

K220732 is an FDA 510(k) clearance for Mural Perinatal Surveillance, manufactured by Ge Medical Systems Information Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K220732 · Ge Medical Systems Information Technologies, Inc. · Obstetrics & Gynecology device
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Jun 2022
Decision
101d
Days
Class 2
Risk

K220732 is an FDA 510(k) clearance for the Mural Perinatal Surveillance. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on June 23, 2022 after a review of 101 days - within the typical 510(k) review window.

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 Ge Medical Systems Information Technologies, Inc. devices

FDA 510(k) Submission Details - K220732

510(k) Number K220732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2022
Decision Date June 23, 2022
Days to Decision 101 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 160d · This submission: 101d
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 156
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K220732.
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K233440 · Philips Medizin Systeme Boeblingen GmbH · Jul 2024
Novii+ Wireless Patch System
K231964 · Datex-Ohmeda · Dec 2023
Bloomlife MFM-Pro
K222327 · Bloom Technologies NV · Feb 2023
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
K200975 · Huntleigh Healthcare Limited · Jun 2020
IntelliSpace Perinatal Rev.K.00
K173941 · Philips Medizin Systeme Boeblingen GmbH · Sep 2018
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · Edan Instruments, Inc. · Aug 2018