Cleared Abbreviated

K013281 - VERSALAB APM

K013281 is an FDA 510(k) clearance for VERSALAB APM, manufactured by Nicolet Biomedical. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Abbreviated 510(k) pathway after a 198-day FDA review.

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

FDA 510(k) Submission Details - K013281

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.

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 98
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K013281.
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