Cleared Abbreviated

GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT (K120922) - FDA 510(k) Clearance

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

K120922 · Selectivemed Components, Inc. · Physical Medicine device
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Feb 2013
Decision
317d
Days
Class 2
Risk

K120922 is an FDA 510(k) clearance for the GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Naples, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Selectivemed Components, Inc. devices

Submission Details

510(k) Number K120922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date February 07, 2013
Days to Decision 317 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

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