Cleared Traditional

K963608 - QUANTITATIVE SENTINEL SYSTEM

K963608 is an FDA 510(k) clearance for QUANTITATIVE SENTINEL SYSTEM, manufactured by Quantitative Medicine, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K963608 · Quantitative Medicine, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
182d
Days
Class 2
Risk

K963608 is an FDA 510(k) clearance for the QUANTITATIVE SENTINEL SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Quantitative Medicine, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 182 days - an extended review cycle.

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. Standard predicate reliance. 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 Quantitative Medicine, Inc. devices

FDA 510(k) Submission Details - K963608

510(k) Number K963608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date March 11, 1997
Days to Decision 182 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
22d slower than avg
Panel avg: 160d · This submission: 182d
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 162
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K963608.
BABY DOPPLEX (3000)
K963711 · Huntleigh Healthcare, Inc. · Sep 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
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
K955931 · Advanced Medical Systems, Inc. · Aug 1996
QUANTITATIVE SENTINEL SYSTEM
K960109 · Quantitative Medicine, Inc. · Aug 1996