# K141157: Bondease Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Optmed, Inc.
- Decided: Dec 22, 2015 after 596 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- 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 P960052 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate), Closure Medical Corp. (1998) Summary page 4.
- P010002: Indermil (TM) Tissue Adhesive, Covidien Lp, Formerly Registered AS United States (2002) Summary page 4.

## Most influential descendants
- K243990: BondEase 2 Topical Skin Adhesive (2025), 0 descendants of its own

## Indications for use
BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.

Source page: https://510kreport.com/device/K141157
Methodology: https://510kreport.com/methodology