# P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate)

- Pathway: PMA
- Applicant: Closure Medical Corp.
- Decided: Aug 26, 1998 after 610 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 6 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K100423: Dermabond NX Adhesive Model: DNX6, DNX12 (2010), 20 descendants of its own
- K130329: Surgiseal Topical Skin Adhesive (2013), 3 descendants of its own
- K130474: Surgiseal Topical Skin Adhesive (2013), 3 descendants of its own
- K123133: Barle Tissue Adhesive (2013), 3 descendants of its own
- K152476: Exofin High Viscosity Tissue Adhesive (2016), 2 descendants of its own

## Recalls of this device
- Feb 2, 2011 · Not classified · Z-1496-2011: Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
- Feb 2, 2011 · Not classified · Z-1497-2011: Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.

Source page: https://510kreport.com/device/P960052
Methodology: https://510kreport.com/methodology