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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 218
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K022645.
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
K030574 · Glustitch, Inc. · Aug 2003
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
K023163 · Medlogic Global Limited · Jan 2003
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
K013225 · Medafor, Inc. · Dec 2001
LIQUIDERM LIQUID ADHESIVE BANDAGE
K002338 · Closure Medical Corp. · Jan 2001
RDH BANDAGE
K002550 · Marine Polymer Technologies, Inc. · Dec 2000
K022645 · CURAD
Download PDF FDA Summary Beiersdorf AG