Cleared Traditional

K820139 - SOF-ROL CAST PADDING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K820139 · Stan-Pak Ent. · General & Plastic Surgery device
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Feb 1982
Decision
17d
Days
Class 1
Risk

K820139 is an FDA 510(k) clearance for the SOF-ROL CAST PADDING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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: 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 Stan-Pak Ent. devices

Submission Details

510(k) Number K820139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1982
Decision Date February 05, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 114d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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.