Cleared Traditional

BLOOM TRANSPARENT STENCIL (K914759) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K914759 · Freckles Publications, Inc. · General & Plastic Surgery device
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Apr 1992
Decision
182d
Days
Class 1
Risk

K914759 is an FDA 510(k) clearance for the BLOOM TRANSPARENT STENCIL. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by Freckles Publications, Inc. (Lubbock, US). The FDA issued a Cleared decision on April 21, 1992 after a review of 182 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4660 - the FDA general and plastic surgery 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K914759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date April 21, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZZ Marker, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4660
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.