510(k) Report

PMA · Approved

Recalled · 2011

Dermabond (a Formulation of 2-Octyl Cyanoacrylate)

P960052PMAApproved Aug 26, 1998610-day reviewClass II21 CFR 878.4010Recalls 2

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

Closure Medical Corp. · MPN Tissue Adhesive For The Topical Approximation Of Skin

Approved on Aug 26, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 610-day review. 24 later devices descend from it. It has been recalled 2 times.

Decided
Aug 26, 1998
Review
610 days
Class
Class II
Product code
MPN
Recalls
2

24 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 4 descendants cleared2013: 6 descendants cleared2010: 1 descendant cleared2014: 4 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceP960052 Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 1998
  2. Descendant · cites it directly · 20 of its ownK100423 Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK130329 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  4. Descendant · 2 generations on · 3 of its ownK130474 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  5. Descendant · cites it directly · 3 of its ownK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
  6. Descendant · 2 generations on · 2 of its ownK152476 Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2010: 12013: 62014: 42015: 42016: 22020: 22021: 12024: 22025: 2
2010high 6 (2013) · low 0 (2011)2026

Most influential descendants

Showing 5 of 24 · See all
  • K100423Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc. · 2010 · cites it directly20descendants
  • K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · 2 generations on3descendants
  • K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · 2 generations on3descendants
  • K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly3descendants
  • K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp.1998—
+1K100423Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc.20101
+2K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—
+2K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—
+1K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.2013—
+2K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201360
201440
201540
201620
202020
202110
202420
202520
FIG. 1 — Lineage of P960052, 1998–2025Source: 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MPN? 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 MPN device

  1. #1 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 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?

PMA decisions do not claim a predicate device.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K100423Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc.201020
K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.20133
K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…ETHICON, Inc.20152
K141157Bondease Topical Skin AdhesiveOptmed, Inc.20151
K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC20141
K121976Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc.20131

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 2, 2011Not classifiedZ-1496-2011Nonconforming Material/ComponentSome units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
Feb 2, 2011Not classifiedZ-1497-2011Nonconforming Material/ComponentSome units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K100423 (ETHICON, Inc., 2010) has gone furthest, with 20 descendants of its own.

How does its category compare?

All MPN devices

MPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MPN

2in 2025

2007: 12008: 12009: 12010: 32011: 22012: 22013: 62014: 42015: 42016: 52020: 22021: 12024: 32025: 2
2007high 6 (2013) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPN

266in 2024

2010: 77 days median2013: 193 days median2014: 96 days median2015: 141 days median2016: 173 days median2024: 266 days median
2007high 266 (2024) · low 77 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MPN

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MPN

244in 2025

2007: 562008: 322009: 222010: 212011: 932012: 1352013: 1772014: 1992015: 1792016: 1942017: 1822018: 2722019: 4272020: 2252021: 1412022: 1652023: 1302024: 2362025: 244
2007high 427 (2019) · low 21 (2010)2025

MAUDE reports naming product code MPN, 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
20071—056
20081—032
20091—022
2010377021
20112—093
20122—0135
201361930177
20144960199
201541410179
201651730194
20170—0182
20180—0272
20190—0427
20202—0225
20211—1141
20220—0165
20230—0130
202432660236
20252—0244
20260—0—

More from Closure Medical Corp.

16 FDA decisions under this applicant name. See the company

  • DEN090005Prineo Skin Closure SystemClosure Medical Corp. · 2010
  • 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

Recent decisions in MPN

The MPN category page

  • K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc. · 2025
  • K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical · 2025
  • K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant Medical · 2024
  • K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd. · 2024
  • K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited. · 2024

https://510kreport.com/device/P960052 · printed Nov 6, 2026

Cite this page

510(k) Report. “P960052: Dermabond (a Formulation of 2-Octyl Cyanoacrylate).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960052

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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