Cleared Traditional

K933228 - KAPTON PEEL POUCH (FDA 510(k) Clearance)

Class I Pathology device.

K933228 · American Fluoroseal Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
271d
Days
Class 1
Risk

K933228 is an FDA 510(k) clearance for the KAPTON PEEL POUCH. Classified as Flask, Tissue Culture (product code KJA), Class I - General Controls.

Submitted by American Fluoroseal Corp. (Silver Spring, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 271 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Fluoroseal Corp. devices

Submission Details

510(k) Number K933228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date March 30, 1994
Days to Decision 271 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 77d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJA Flask, Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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.