Cleared Abbreviated

VERSALAB APM (K013281) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K013281 · Nicolet Biomedical · Obstetrics & Gynecology device
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Apr 2002
Decision
198d
Days
Class 2
Risk

K013281 is an FDA 510(k) clearance for the VERSALAB APM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Nicolet Biomedical (Golden, US). The FDA issued a Cleared decision on April 18, 2002 after a review of 198 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nicolet Biomedical devices

Submission Details

510(k) Number K013281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date April 18, 2002
Days to Decision 198 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 160d · This submission: 198d
Pathway characteristics
Standards-based clearance path.

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 27
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K013281.
AlertWatch:OB
K173715 · Alertwatch, Inc. · Apr 2018
Central Monitoring System
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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 M1353A FETAL MONITOR
K921956 · Hewlett-Packard Co. · Sep 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993