Cleared Special

K032772 - MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM

K032772 is an FDA 510(k) clearance for MODIFICATION TO WATCHCHILD OBSTETRICAL ..., manufactured by Hill-Rom Manufacturing, Inc.. 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.

K032772 · Hill-Rom Manufacturing, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
30d
Days
Class 2
Risk

K032772 is an FDA 510(k) clearance for the MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO R.... Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Hill-Rom Manufacturing, Inc. (Cary, US). The FDA issued a Cleared decision on October 8, 2003 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 - K032772

510(k) Number K032772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date October 08, 2003
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 191
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K032772.
AIRSTRIP OB
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MODEL 120 SERIES MATERNAL/FETAL MONITOR
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BATTERY, RECHARGEABLE
K030261 · Access Battery, Inc. · Apr 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
K023931 · Philips Medical Systems, Inc. · Feb 2003
K032772 · MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
Download PDF FDA Summary Hill-Rom Manufacturin…