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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 149d · 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 Consultant

Entela, Inc.
NED DEVINE

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 - IKN Electromyograph, Diagnostic

All 71
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K033452.
INSIGHT DISCOVERY
K063447 · Fasstech · Aug 2007
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K052112 · Excel Tech. , Ltd. · Oct 2005
COMPREHENSIVE NEUROMUSCULAR PROFILER
K031995 · Medical Technologies Unlimited, Inc. · Jan 2004
INSIGHT MILLENNIUM III
K023209 · Fasstech · Oct 2003
NIM-PRS
K024316 · Medtronic Xomed, Inc. · Jan 2003
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
K023147 · Bortec Biomedical, Ltd. · Dec 2002
K033452 · CWAS 1000
Download PDF FDA Summary Fasstech