Cleared Traditional

Aleo BME Liquid Bandage (K171148) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K171148 · Aleo Bme, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
268d
Days
Class 1
Risk

K171148 is an FDA 510(k) clearance for the Aleo BME Liquid Bandage. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Aleo Bme, Inc. (State College, US). The FDA issued a Cleared decision on January 12, 2018 after a review of 268 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.

View all Aleo Bme, Inc. devices

Submission Details

510(k) Number K171148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2017
Decision Date January 12, 2018
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 Consultant

Msquared Associates, Inc.
LeAnn Latham

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KMF Bandage, Liquid

All 19
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K171148.
TearRepair Liquid Skin Protectant
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Rochal Bioshield Silicone Film
K182733 · Rochal Industries, LLC · Jun 2019
3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
ASKINA HYDROCOLLOID/THIN
K973227 · B.Braun Medical, Inc. · Jan 1999