# DEN090005: Prineo Skin Closure System

- Pathway: De Novo (Post-NSE)
- Applicant: Closure Medical Corp.
- Decided: Apr 30, 2010 after 402 days
- Product code: OMD (Cutaneous Tissue Adhesive With Mesh)
- Device class: 2
- Regulation: 21 CFR 878.4011
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K133864: Dermabond Prineo Skin Closure System (2014), 9 descendants of its own
- K171442: Exofin Fusion Skin Closure System (2017), 2 descendants of its own
- K234114: CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System (RM-1739) (2024), 1 descendant of its own
- K191461: Exofin Fusion Skin Closure System (2020), 1 descendant of its own
- K250950: CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/DEN090005
Methodology: https://510kreport.com/methodology