# K241916: TearRepair Liquid Skin Protectant

- Pathway: 510(k) (Traditional)
- Applicant: Optmed, Inc.
- Decided: Sep 27, 2024 after 88 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K133443 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133443: Marathon NO Sting Liquid Skin Protectant, Advanced Medical Solutions (Plymouth), Ltd. (2014) Summary page 5.

## Indications for use
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, clothing, shoes, or any material that may damage the skin. TearRepair can also be used to protect skin exposed to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.

Source page: https://510kreport.com/device/K241916
Methodology: https://510kreport.com/methodology