Cleared Traditional

K983395 - FETALGARD 3000 FETAL MONITOR

K983395 is the FDA 510(k) clearance for FETALGARD 3000 FETAL MONITOR by Analogic Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K983395 · Analogic Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
321d
Days
Class 2
Risk

K983395 is an FDA 510(k) clearance for the FETALGARD 3000 FETAL MONITOR. 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 August 12, 1999 after a review of 321 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 Analogic Corp. devices

Submission Details

510(k) Number K983395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date August 12, 1999
Days to Decision 321 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
161d slower than avg
Panel avg: 160d · This submission: 321d
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 K983395.
COROMETRICS MODEL 173 FETAL MONITOR
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COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K991905 · General Electric Medical Systems Information Techn · Sep 1999
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K991739 · General Electric Medical Systems Information Techn · Aug 1999
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · Air-Shields, Inc. · Oct 1998
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · Spacelabs Medical, Inc. · Dec 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K971099 · Alexander Mfg. Co. · Jun 1997