Cleared Traditional

HEWLETT PACKARD MODEL M1353A FETAL MONITOR (K921956) - FDA 510(k) Clearance

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

K921956 · Hewlett-Packard Co. · Obstetrics & Gynecology device
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Sep 1993
Decision
515d
Days
Class 2
Risk

K921956 is an FDA 510(k) clearance for the HEWLETT PACKARD MODEL M1353A FETAL MONITOR. 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 September 24, 1993 after a review of 515 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K921956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date September 24, 1993
Days to Decision 515 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
355d slower than avg
Panel avg: 160d · This submission: 515d
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 K921956.
Central Monitoring System
K171178 · Edan Instruments, Inc. · Sep 2017
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · Hewlett-Packard Co. · Jul 1990
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · Hewlett-Packard Co. · Aug 1989