Cleared Special

K081203 - OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00

K081203 is an FDA 510(k) clearance for OB TRACEVUE OBSTETRICAL INFORMATION MAN..., manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Special 510(k) pathway after a 30-day FDA review.

K081203 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
30d
Days
Class 2
Risk

K081203 is an FDA 510(k) clearance for the OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on May 28, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081203

510(k) Number K081203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date May 28, 2008
Days to Decision 30 days
Submission Type Special
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
131d faster than avg
Panel avg: 161d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 214
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K081203.
AIRSTRIP OB
K090061 · Airstrip Technologies, LP · Jan 2009
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · Edan Instruments, Inc. · Nov 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc. · Nov 2008
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
K080226 · Hill-Rom Manufacturing, Inc. · Apr 2008
CADENCE II
K073221 · Edan Instruments, Inc. · Dec 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
K081203 · OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
Download PDF FDA Summary Philips Medizin Syste…