Cleared Traditional

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM (K852608) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852608 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Sep 1985
Decision
100d
Days
Class 2
Risk

K852608 is an FDA 510(k) clearance for the SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on September 27, 1985 after a review of 100 days - within the typical 510(k) review window.

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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K852608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date September 27, 1985
Days to Decision 100 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
60d faster than avg
Panel avg: 160d · This submission: 100d
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 56
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K852608.
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · Ge Medical Systems Information Technologies · Jun 1988
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co. · Jul 1986
MODEL 145 FETAL MONITOR
K852076 · Ge Medical Systems Information Technologies · Jul 1985
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
K851252 · Ge Medical Systems Information Technologies · May 1985
COROMETRICS FETAL MONITOR 142
K843918 · Ge Medical Systems Information Technologies · Dec 1984