Cleared Traditional

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM (K861544) - FDA 510(k) Clearance

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

K861544 · Hewlett-Packard Co. · Obstetrics & Gynecology device
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Jul 1986
Decision
85d
Days
Class 2
Risk

K861544 is an FDA 510(k) clearance for the MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on July 18, 1986 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K861544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date July 18, 1986
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
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 26
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K861544.
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · Hewlett-Packard Co. · Jul 1990
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · Hewlett-Packard Co. · Aug 1989
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · Hewlett-Packard Co. · Sep 1978
MODEL 80100A, PATIENT DATA MEMORY
K781360 · Hewlett-Packard Co. · Sep 1978
FETAL/MATERNAL ALRM MODULE - 21595A
K771194 · Hewlett-Packard Co. · Aug 1977