510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Dermabond Prineo Skin Closure System

K133864510(k) SpecialCleared Mar 10, 201481-day reviewClass II21 CFR 878.4011Recalls 1

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

ETHICON, Inc. · OMD Cutaneous Tissue Adhesive With Mesh

Cleared on Mar 10, 2014 as substantially equivalent to DEN090005 (Closure Medical Corp., 2010) after an 81-day review. Its family tree reaches back 1 generation to 2010. 9 later devices descend from it. It has been recalled once.

Decided
Mar 10, 2014
Review
81 days
Class
Class II
Product code
OMD
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to DEN090005 (2010). 9 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedDEN090005 · Prineo Skin Closure System · Closure Medical Corp. · 20102010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant DEN090005 · Prineo Skin Closure System · Closure Medical Corp. · 20100
  1. Root · 1 generation backDEN090005 Prineo Skin Closure SystemClosure Medical Corp. · 2010
  2. This deviceK133864 Dermabond Prineo Skin Closure SystemETHICON, Inc. · 2014
  3. Descendant · cites it directly · 2 of its ownK171442 Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017
  4. Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK250950 CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure…Okapi Medical, LLC Dba Resivant Medical · 2025
  7. Descendant · cites it directly · 0 of its ownK233460 CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd. · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015: 12017: 22020: 12021: 12022: 12024: 22025: 1
2015high 2 (2017) · low 0 (2016)2026

Most influential descendants

Showing 5 of 9 · See all
  • 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 · cites it directly1descendant
  • 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 · 2 generations on0descendants
  • K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN090005Prineo Skin Closure SystemClosure Medical Corp.2010—
0 (this device)K133864Dermabond Prineo Skin Closure SystemETHICON, Inc.2014—
+1K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.2017—
+1K234114CUTIVA (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—
+2K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical2025—
+1K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201720
202010
202110
202210
202420
202510
FIG. 1 — Lineage of K133864, 2010–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN090005Prineo Skin Closure System
Our reading of the summary gave K082289, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090005, Prineo Skin Closure System (Closure Medical Corp.), granted Apr 30, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
Closure Medical Corp.2010—

Also cleared against DEN090005: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc.20172
K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical20241
K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical, Ltd.20240
K213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc.20210
K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC20170
K152490DERMABOND PRINEO Skin Closure SystemETHICON, Inc.20150

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 27, 2017Class IIZ-1147-2018Component change controlEthicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K171442 (Chemence Medical, Inc., 2017) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate DEN090005.

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. 2014, 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—

What is it indicated for?

DERMABOND PRINEO Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Indications for use as stated in the FDA summary.

Also cleared against DEN090005

2 other devices cite the same predicate.

  • K171442Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017
  • K152490DERMABOND PRINEO Skin Closure SystemETHICON, Inc. · 2015

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

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/K133864 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133864: Dermabond Prineo Skin Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133864

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026