Aleo BME Liquid Bandage

FDA 510(k) K171148 · Aleo Bme, Inc.

Substantially Equivalent

510(k) numberK171148

Submission

Device name
Aleo BME Liquid Bandage
Applicant
Aleo Bme, Inc.
State College, PA, US
Received
April 19, 2017
Decision date
January 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KMF – Bandage, Liquid
Device class
Class I (low risk)
Regulation
21 CFR 880.5090
Specialty
General Hospital

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K241916TearRepair Liquid Skin ProtectantKMF · Traditional Optmed, Inc.09/27/2024SE
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K153571Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional 3M Healthcare08/23/2016SE
K160684Atteris No-Sting Skin ProtectantKMF · Traditional Rochal Industries, LLC07/26/2016SE
K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional Kericure, Inc.08/07/2014SE
K133443Marathon No Sting Liquid Skin ProtectantKMF · Traditional Advanced Medical Solutions (Plymouth), Ltd.07/10/2014SE
K120059Liquid BandageKMF · Traditional Chesson Laboratory Associates, Inc.05/17/2012SE
K092712Skin Barrier FilmKMF · Traditional Lodestar Products, Inc.02/23/2010SE
K083087EcocelKMF · Traditional Polichem S.A08/07/2009SE
K083913Chesson Labs Liquid BandageKMF · Traditional Chesson Laboratory Associates, Inc.07/31/2009SE

Questions and answers

When was Aleo BME Liquid Bandage cleared by the FDA?

Aleo BME Liquid Bandage (K171148) received a 510(k) decision of Substantially Equivalent on January 12, 2018, 268 days after the submission was received.

What is the product code of K171148?

The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.