Cleared Traditional

K022645 - CURAD

K022645 is an FDA 510(k) clearance for CURAD, manufactured by Beiersdorf AG. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K022645 · Beiersdorf AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
89d
Days
Class 1
Risk

K022645 is an FDA 510(k) clearance for the CURAD. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Beiersdorf AG (North Attleboro, US). The FDA issued a Cleared decision on November 5, 2002 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Beiersdorf AG devices

FDA 510(k) Submission Details - K022645

510(k) Number K022645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2002
Decision Date November 05, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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.

Regulatory Peers - KMF Bandage, Liquid

All 143
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K022645.
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