Cleared Traditional

K823081 - M2100 ANTEPARTUM FETAL MONITOR

K823081 is an FDA 510(k) clearance for M2100 ANTEPARTUM FETAL MONITOR, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K823081 · Huntleigh Technology, Inc. · Obstetrics & Gynecology device
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Jan 1983
Decision
99d
Days
Class 2
Risk

K823081 is an FDA 510(k) clearance for the M2100 ANTEPARTUM FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 99 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 Huntleigh Technology, Inc. devices

FDA 510(k) Submission Details - K823081

510(k) Number K823081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date January 26, 1983
Days to Decision 99 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
61d faster than avg
Panel avg: 160d · This submission: 99d
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 101
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K823081.
COROMETRICS 115 FETAL MONITOR
K843385 · Ge Medical Systems Information Technologies · Nov 1984
COROMETRICS 815 FETAL ECG RECORDER
K841477 · Ge Medical Systems Information Technologies · May 1984
FETAL MONITOR #115
K831852 · Ge Medical Systems Information Technologies · Aug 1983
M2000 INTRAPARTUM FETAL MONITOR
K823188 · Huntleigh Technology, Inc. · Jan 1983
FETASONDE 5, #30, CENTRAL NURSING STAT
K812863 · Kontron Instruments, Inc. · Nov 1981
TERUMO FETAL MONITOR # FHM-602
K801747 · Terumo Medical Corp. · Aug 1980