Cleared Traditional

K880419 - MODEL 800 O.B. DATA ARCHIVAL SYSTEM

K880419 is an FDA 510(k) clearance for MODEL 800 O.B. DATA ARCHIVAL SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K880419 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Jun 1988
Decision
130d
Days
Class 2
Risk

K880419 is an FDA 510(k) clearance for the MODEL 800 O.B. DATA ARCHIVAL 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 June 10, 1988 after a review of 130 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

FDA 510(k) Submission Details - K880419

510(k) Number K880419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date June 10, 1988
Days to Decision 130 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
30d faster than avg
Panel avg: 160d · This submission: 130d
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 99
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K880419.
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · Hewlett-Packard Co. · Aug 1989
MODEL 116 FETAL MONITOR
K891595 · Ge Medical Systems Information Technologies · Jun 1989
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K882966 · Ge Medical Systems Information Technologies · Oct 1988
FETALERT ADR FETAL MONITOR
K871383 · Advanced Technology Laboratories, Inc. · Jun 1987
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
K871385 · Fukuda Denshi USA, Inc. · May 1987
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986