# MPN: Tissue Adhesive For The Topical Approximation Of Skin

- Device class: 2; regulation: 21 CFR 878.4010; FDA's rule: 510(k) required
- FDA decisions: 39
- 510(k) review time 2021–2025: median 252 days (middle half 156–267)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 2
- 2012: 2
- 2013: 6
- 2014: 4
- 2015: 4
- 2016: 5
- 2020: 2
- 2021: 1
- 2024: 3
- 2025: 2

## Most-cited predicates
- K100423: Dermabond NX Adhesive Model: DNX6, DNX12 (2010), cited by 8
- K082993: Surgiseal Topical Skin Adhesive (2008), cited by 7
- P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate) (1998), cited by 6
- K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404 (2010), cited by 5
- P010002: Indermil (TM) Tissue Adhesive (2002), cited by 4
- K130329: Surgiseal Topical Skin Adhesive (2013), cited by 3
- K100284: Liquiband Ultima, Lut 003 (2010), cited by 3
- K130474: Surgiseal Topical Skin Adhesive (2013), cited by 3
- K083531: Liquiband Ultima, Model LB0004 (2009), cited by 2
- K111959: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive (2012), cited by 2

Source page: https://510kreport.com/product-code/MPN
Data by year (CSV): https://510kreport.com/product-code/MPN.csv