Cleared Traditional

K023931 - PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A

K023931 is an FDA 510(k) clearance for PHILIPS AVALON CTS CORDLESS FETAL TRANS..., manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023931 · Philips Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
90d
Days
Class 2
Risk

K023931 is an FDA 510(k) clearance for the PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M.... Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Da Best, NL). The FDA issued a Cleared decision on February 24, 2003 after a review of 90 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 Philips Medical Systems, Inc. devices

FDA 510(k) Submission Details - K023931

510(k) Number K023931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date February 24, 2003
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 159
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K023931.
AIRSTRIP OB
K042082 · Mp4 Solutions, LP · Jan 2005
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc. · Sep 2004
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · Card Guard Scientific Survival , Ltd. · Aug 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · Ge Medical Systems Information Technologies · May 2002
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001