Cleared Traditional

K960109 - QUANTITATIVE SENTINEL SYSTEM

K960109 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 203-day FDA review.

K960109 · Quantitative Medicine, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
203d
Days
Class 2
Risk

K960109 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. (Annapolis, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 203 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 - K960109

510(k) Number K960109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date August 01, 1996
Days to Decision 203 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
43d slower than avg
Panel avg: 160d · This submission: 203d
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 K960109.
QUANTITATIVE SENTINEL SYSTEM
K963608 · Quantitative Medicine, Inc. · Mar 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
SERIES 50XM
K954351 · Hewlett-Packard GmbH · Mar 1996
COROMETRICS FETAL MOVEMENT DETECTION KIT
K955559 · Ge Medical Systems Information Technologies · Mar 1996
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K950420 · Analogic Corp. · May 1995