Cleared Traditional

K201309 - ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (FDA 510(k) Clearance)

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

K201309 · Mecta Corporation · Neurology device
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Jun 2021
Decision
385d
Days
Class 2
Risk

K201309 is an FDA 510(k) clearance for the ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Mecta Corporation (Tualatin, US). The FDA issued a Cleared decision on June 4, 2021 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K201309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2020
Decision Date June 04, 2021
Days to Decision 385 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 148d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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.