Cleared Traditional

K910169 - FETALGARD 2000

K910169 is the FDA 510(k) clearance for FETALGARD 2000 by Analogic Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K910169 · Analogic Corp. · Obstetrics & Gynecology device
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Jul 1991
Decision
188d
Days
Class 2
Risk

K910169 is an FDA 510(k) clearance for the FETALGARD 2000. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 188 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 Analogic Corp. devices

Submission Details

510(k) Number K910169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date July 22, 1991
Days to Decision 188 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 160d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 97
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K910169.
COROMETRICS MODEL 150 FETAL MONITOR
K920376 · Ge Medical Systems Information Technologies · Apr 1992
MODEL SONICAID AXIS
K912890 · Oxford Medilog, Inc. · Jan 1992
SONICAID TEAM
K912639 · Oxford Medilog, Inc. · Dec 1991
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
K910418 · Graphic Controls Corp. · Jul 1991
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K910260 · Ge Medical Systems Information Technologies · Mar 1991
CATALOG NUMBER 2609 LEG PLATE
K905295 · Ge Medical Systems Information Technologies · Feb 1991