510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Dermabond NX Adhesive Model: DNX6, DNX12

K100423510(k) TraditionalCleared May 4, 201077-day reviewClass II21 CFR 878.4010Recalls 1

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

ETHICON, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin

Cleared on May 4, 2010 as substantially equivalent to P960052 (Closure Medical Corp., 1998) after a 77-day review. Its family tree reaches back 1 generation to 1998. 20 later devices descend from it. It has been recalled once.

Decided
May 4, 2010
Review
77 days
Class
Class II
Product code
MPN
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to P960052 (1998). 20 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2024: 2 descendants cleared2013: 5 descendants cleared2015: 3 descendants cleared2014: 3 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared2021: 1 descendant clearedP960052 · Dermabond (a Formulation of 2-Octyl Cyanoacrylate) · Closure Medical Corp. · 1998 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 9 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant P960052 · Dermabond (a Formulation of 2-Octyl Cyanoacrylate) · Closure Medical Corp. · 1998 · recalled0
  1. Root · 1 generation backP960052 Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 1998 · Recalled
  2. This deviceK100423 Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc. · 2010
  3. Descendant · cites it directly · 3 of its ownK130329 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  4. Descendant · cites it directly · 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 · cites it directly · 2 of its ownK152476 Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016
  7. Descendant · cites it directly · 2 of its ownK152096 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND…ETHICON, Inc. · 2015 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013: 52014: 32015: 32016: 22020: 22021: 12024: 22025: 2
2013high 5 (2013) · low 0 (2017)2026

Most influential descendants

Showing 5 of 20 · See all
  • K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly3descendants
  • K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly3descendants
  • K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly3descendants
  • K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016 · cites it directly2descendants
  • K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…ETHICON, Inc. · 2015 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp.19982
0 (this device)K100423Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc.2010—
+1K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—
+1K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—
+1K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.2013—
+1K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.2016—
+1K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini…ETHICON, Inc.20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201350
201430
201530
201620
202020
202110
202420
202520
FIG. 1 — Lineage of K100423, 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 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 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

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
*P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)
Summary page 1
…Topical Skin Adhesive Classification Name: Tissue Adhesive for the Topical Approximation of Skin Product Code: MPN Predicate Device: DERMABOND® Topical Skin Adhesive (P960052): Reclassified frorf Class Ill PMA to Class 11510(k) - May 5, 2005- Docket number 2006p-O7l. Device Description: DERMABOND® NX…
Closure Medical Corp.19982

Also cleared against P960052: 5 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133
K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133
K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.20133
K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.20162
K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…ETHICON, Inc.20152
K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20132
K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical20241
K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc.20160

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 4, 2021Class IIZ-0953-2021Packaging process controlProduct distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K130329 (Adhezion Biomedical, LLC, 2013) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate P960052.

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. 2010, this device’s year, is highlighted.

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—

What is it indicated for?

DERMABOND NX Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND NX Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Indications for use as stated in the FDA summary.

Also cleared against P960052

5 other devices cite the same predicate.

  • K141157Bondease Topical Skin AdhesiveOptmed, Inc. · 2015
  • K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin AdhesiveETHICON, Inc. · 20151 recall
  • K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
  • K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
  • K121976Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc. · 2013

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 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/K100423 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100423: Dermabond NX Adhesive Model: DNX6, DNX12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100423

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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