Cleared Traditional

K033452 - CWAS 1000

K033452 is an FDA 510(k) clearance for CWAS 1000, manufactured by Fasstech. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K033452 · Fasstech · Neurology device
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Nov 2003
Decision
29d
Days
Class 2
Risk

K033452 is an FDA 510(k) clearance for the CWAS 1000. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Fasstech (North Billerica, US). The FDA issued a Cleared decision on November 28, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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.

View all Fasstech devices

FDA 510(k) Submission Details - K033452

510(k) Number K033452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date November 28, 2003
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Peers - IKN Electromyograph, Diagnostic

All 31
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K033452.
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