Cleared Abbreviated

K100524 - POLYTEL(R) APT MODEL: PWA-08-01

K100524 is an FDA 510(k) clearance for POLYTEL APT MODEL: PWA-08-01, manufactured by Polymap Wireless, LLC. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Abbreviated 510(k) pathway after a 89-day FDA review.

K100524 · Polymap Wireless, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
89d
Days
Class 2
Risk

K100524 is an FDA 510(k) clearance for the POLYTEL(R) APT MODEL: PWA-08-01. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Polymap Wireless, LLC (Tucson, US). The FDA issued a Cleared decision on May 24, 2010 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K100524

510(k) Number K100524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date May 24, 2010
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 188
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K100524 · POLYTEL(R) APT MODEL: PWA-08-01
Download PDF FDA Summary Polymap Wireless, LLC