Cleared Traditional

K031321 - LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001

K031321 is an FDA 510(k) clearance for LIQUISHIELD LIQUID BANDAGE, manufactured by Medlogic Global Limited. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K031321 · Medlogic Global Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
271d
Days
Class 1
Risk

K031321 is an FDA 510(k) clearance for the LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medlogic Global Limited (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on January 21, 2004 after a review of 271 days - an extended review 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: 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.

FDA 510(k) Submission Details - K031321

510(k) Number K031321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2003
Decision Date January 21, 2004
Days to Decision 271 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
156d slower than avg
Panel avg: 115d · This submission: 271d
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 217
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K031321.
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · Medtrade Products , Ltd. · Nov 2005
ELASTIC SKIN LIQUID BANDAGE
K032948 · Medpak, LLC · Jun 2004
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
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
K031321 · LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
Download PDF FDA Summary Medlogic Global Limit…