Cleared Traditional

K131338 - DERMA HOOD (FDA 510(k) Clearance)

Class I General Hospital device.

K131338 · Globalmedia Group, LLC · General Hospital
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Jul 2013
Decision
62d
Days
Class 1
Risk

K131338 is an FDA 510(k) clearance for the DERMA HOOD. Classified as Accessories To Examination Light (product code PEQ), Class I - General Controls.

Submitted by Globalmedia Group, LLC (Scottsdale, US). The FDA issued a Cleared decision on July 10, 2013 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - the FDA general hospital 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 Globalmedia Group, LLC devices

Submission Details

510(k) Number K131338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2013
Decision Date July 10, 2013
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PEQ Accessories To Examination Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
Definition Accessories That Attach To The Light And Assist In Magnifying, Clarifying, Enhancing The Image Being Viewed.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.