Cleared Traditional

K111985 - MYOGUIDE SYSTEM MODEL 8008 (FDA 510(k) Clearance)

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

K111985 · Intronix Technologies Corp. · Anesthesiology device
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Dec 2011
Decision
171d
Days
Class 2
Risk

K111985 is an FDA 510(k) clearance for the MYOGUIDE SYSTEM MODEL 8008. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Intronix Technologies Corp. (Austin, US). The FDA issued a Cleared decision on December 30, 2011 after a review of 171 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intronix Technologies Corp. devices

Submission Details

510(k) Number K111985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2011
Decision Date December 30, 2011
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 139d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.