Cleared Traditional

FETAL CARE MONITOR ANTEPARTUM 1500 (K871082) - FDA 510(k) Clearance

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

K871082 · Pie Data Medical BV · Obstetrics & Gynecology device
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Aug 1987
Decision
139d
Days
Class 2
Risk

K871082 is an FDA 510(k) clearance for the FETAL CARE MONITOR ANTEPARTUM 1500. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Pie Data Medical BV (Maastricht 6227 Aj, NL). The FDA issued a Cleared decision on August 4, 1987 after a review of 139 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 Pie Data Medical BV devices

Submission Details

510(k) Number K871082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date August 04, 1987
Days to Decision 139 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 160d · This submission: 139d
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 56
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K871082.
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
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · Ge Medical Systems Information Technologies · Jun 1988
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co. · Jul 1986
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K852608 · Ge Medical Systems Information Technologies · Sep 1985