510(k) Report

De Novo · Granted

Granted

Prineo Skin Closure System

DEN090005De NovoGranted Apr 30, 2010402-day reviewClass II21 CFR 878.4011

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Closure Medical Corp. · OMD Cutaneous Tissue Adhesive With Mesh

Granted on Apr 30, 2010 as a new device type through De Novo after a 402-day review. 10 later devices descend from it.

Decided
Apr 30, 2010
Review
402 days
Class
Class II
Product code
OMD
Recalls
None

10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2010201520202025
  1. This deviceDEN090005 Prineo Skin Closure SystemClosure Medical Corp. · 2010
  2. Descendant · cites it directly · 9 of its ownK133864 Dermabond Prineo Skin Closure SystemETHICON, Inc. · 2014 · Recalled
  3. Descendant · cites it directly · 2 of its ownK171442 Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017
  4. Descendant · 2 generations on · 1 of its ownK234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin…Okapi Medical, LLC Dba Resivant Medical · 2024
  5. Descendant · 2 generations on · 1 of its ownK191461 Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2020
  6. Descendant · 3 generations on · 0 of its ownK250950 CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure…Okapi Medical, LLC Dba Resivant Medical · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 22020: 12021: 12022: 12024: 22025: 1
2014high 2 (2017) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K133864Dermabond Prineo Skin Closure SystemETHICON, Inc. · 2014 · cites it directly9descendants
  • K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017 · cites it directly2descendants
  • K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical · 2024 · 2 generations on1descendant
  • K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2020 · 2 generations on1descendant
  • K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN090005Prineo Skin Closure SystemClosure Medical Corp.2010—
+1K133864Dermabond Prineo Skin Closure SystemETHICON, Inc.20141
+1K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.2017—
+2K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure…Okapi Medical, LLC Dba Resivant Medical2024—
+2K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc.2020—
+3K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201720
202010
202110
202210
202420
202510
FIG. 1 — Lineage of DEN090005, 2010–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OMD device

  1. #1 K233460 CM00622 LINC Skin Closure System (CM00622 LINC)score 8.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133864Dermabond Prineo Skin Closure SystemETHICON, Inc.20149
K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.20172
K152490DERMABOND PRINEO Skin Closure SystemETHICON, Inc.20150

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K133864 (ETHICON, Inc., 2014) has gone furthest, with 9 descendants of its own.

How does its category compare?

All OMD devices

OMD Cutaneous Tissue Adhesive With Mesh: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OMD

1in 2024

2010: 12014: 12015: 12017: 22020: 12021: 12022: 12024: 1
2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMD

Too few OMD 510(k)s in any year since 2007 to give a median.

Recalls per year · OMD

No recall names OMD since 2007.

Adverse event reports per year · OMD

288in 2025

2012: 252013: 542014: 172015: 942016: 1252017: 1632018: 2062019: 1532020: 862021: 1862022: 1752023: 1712024: 2562025: 288
2007high 288 (2025) · low 0 (2007)2025

MAUDE reports naming product code OMD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—025
20130—054
20141—017
20151—094
20160—0125
20172—0163
20180—0206
20190—0153
20201—086
20211—0186
20221—0175
20230—0171
20241—0256
20250—0288
20260—0—

More from Closure Medical Corp.

16 FDA decisions under this applicant name. See the company

  • P960052/S012Dermabond Topical Skin AdhesiveClosure Medical Corp. · 2006
  • P960052/S011High Viscosity Dermabond Mini ApplicatorClosure Medical Corp. · 2006
  • P960052/S010High Viscosity Dermabond Topical Skin AdhesiveClosure Medical Corp. · 2005
  • P960052/S009Dermabond Topical Skin AdhesiveClosure Medical Corp. · 2004
  • P960052/S007Dermabond Topical Skin AdhesiveClosure Medical Corp. · 2003

Recent decisions in OMD

The OMD category page

  • K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd. · 2024
  • K211878LiquiBand XLAdvanced Medical Solutions Limited · 2022
  • K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc. · 2021
  • K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2020
  • K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017

https://510kreport.com/device/DEN090005 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN090005: Prineo Skin Closure System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN090005

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026