Cleared Traditional

K002550 - RDH BANDAGE

K002550 is an FDA 510(k) clearance for RDH BANDAGE, manufactured by Marine Polymer Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K002550 · Marine Polymer Technologies, Inc. · General & Plastic Surgery device
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Dec 2000
Decision
125d
Days
Class 1
Risk

K002550 is an FDA 510(k) clearance for the RDH BANDAGE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 20, 2000 after a review of 125 days - within the typical 510(k) review window.

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: 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.

View all Marine Polymer Technologies, Inc. devices

FDA 510(k) Submission Details - K002550

510(k) Number K002550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date December 20, 2000
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
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 92
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K002550.
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · Medtrade Products , Ltd. · Nov 2005
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K991729 · Ferris Mfg. Corp. · Aug 1999
DYNAREX DRAIN SPONGE
K991694 · Dynarex Corp. · Jul 1999
DYNAREX NON-WOVEN SPONGE
K991695 · Dynarex Corp. · Jul 1999