Cleared Traditional

K963711 - BABY DOPPLEX (3000)

K963711 is an FDA 510(k) clearance for BABY DOPPLEX (3000), manufactured by Huntleigh Healthcare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K963711 · Huntleigh Healthcare, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
361d
Days
Class 2
Risk

K963711 is an FDA 510(k) clearance for the BABY DOPPLEX (3000). Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Healthcare, Inc. (Manalapan, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Huntleigh Healthcare, Inc. devices

FDA 510(k) Submission Details - K963711

510(k) Number K963711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date September 12, 1997
Days to Decision 361 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
200d slower than avg
Panel avg: 161d · This submission: 361d
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 178
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K963711.
CALM
K980719 · Lms Medical Systems , Ltd. · Jul 1998
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · Spacelabs Medical, Inc. · Dec 1997
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
K970456 · Hewlett-Packard GmbH · Oct 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K971099 · Alexander Mfg. Co. · Jun 1997
CARD GUARD MODEL CG-900
K960553 · Card Guard Scientific Survival , Ltd. · Apr 1997
QUANTITATIVE SENTINEL SYSTEM
K963608 · Quantitative Medicine, Inc. · Mar 1997