Cleared Special

K010894 - BABY DOPPLEX 3002 (BD3002)

K010894 is an FDA 510(k) clearance for BABY DOPPLEX 3002 (BD3002), manufactured by Huntleigh Healthcare, 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.

K010894 · Huntleigh Healthcare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010894 is an FDA 510(k) clearance for the BABY DOPPLEX 3002 (BD3002). Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Healthcare, Inc. (Cardiff, GB). The FDA issued a Cleared decision on April 25, 2001 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.

View all Huntleigh Healthcare, Inc. devices

FDA 510(k) Submission Details - K010894

510(k) Number K010894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date April 25, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · 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 102
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K010894.
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
FETALGARD LITE
K002503 · Analogic Corp. · Nov 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K991905 · General Electric Medical Systems Information Techn · Sep 1999