Cleared Traditional

K040932 - EASYNET BODY POSITION MODULE

K040932 is an FDA 510(k) clearance for EASYNET BODY POSITION MODULE, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code LEL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K040932 · Cadwell Laboratories, Inc. · Neurology device
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Jul 2004
Decision
83d
Days
Class 2
Risk

K040932 is an FDA 510(k) clearance for the EASYNET BODY POSITION MODULE. Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 - K040932

510(k) Number K040932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2004
Decision Date July 01, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 149d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEL Device Classification - Class 2, Special Controls

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - LEL Device, Sleep Assessment

All 15
Devices cleared under the same product code (LEL) and FDA review panel - the closest regulatory comparables to K040932.
ActTrust
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