Cleared Special

K014094 - MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM

K014094 is an FDA 510(k) clearance for MODIFICATION TO THE WATCHCHILD OBSTETRI..., 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.

K014094 · 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
Jan 2002
Decision
30d
Days
Class 2
Risk

K014094 is an FDA 510(k) clearance for the MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM. 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 January 11, 2002 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 - K014094

510(k) Number K014094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2001
Decision Date January 11, 2002
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 K014094.
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
VERSALAB APM
K013281 · Nicolet Biomedical · Apr 2002
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001
OB-1 FETAL MONITOR
K011304 · Analogic Corp. · May 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd. · May 2001
K014094 · MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Download PDF FDA Summary Hill-Rom Manufacturin…