Cleared Traditional

K061343 - INSPIRSTAR GLOVE ELECTRODE

K061343 is an FDA 510(k) clearance for INSPIRSTAR GLOVE ELECTRODE, manufactured by Inspirstar, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K061343 · Inspirstar, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
16d
Days
Class 2
Risk

K061343 is an FDA 510(k) clearance for the INSPIRSTAR GLOVE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Inspirstar, Inc. (Chandler, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K061343

510(k) Number K061343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date May 31, 2006
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 149d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

All 409
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K061343 · INSPIRSTAR GLOVE ELECTRODE
Download PDF FDA Summary Inspirstar, Inc.