Cleared Traditional

MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM (K942887) - FDA 510(k) Clearance

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

K942887 · Hewlett-Packard Co. · Obstetrics & Gynecology device
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Aug 1994
Decision
56d
Days
Class 2
Risk

K942887 is an FDA 510(k) clearance for the MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on August 15, 1994 after a review of 56 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 K942887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date August 15, 1994
Days to Decision 56 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
104d faster than avg
Panel avg: 160d · This submission: 56d
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 K942887.
AlertWatch:OB
K173715 · Alertwatch, Inc. · Apr 2018
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · Hewlett-Packard Co. · Jul 1990