510(k) · Cleared
Recalled · Class II · 2021DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Oct 22, 2015 as substantially equivalent to K100423 (ETHICON, Inc., 2010) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 22, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- MPN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to P960052 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP960052 Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 1998 · Recalled
- 1 generation backK100423 Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc. · 2010 · Recalled
- This deviceK152096 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND…ETHICON, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK243990 BondEase 2 Topical Skin AdhesiveOptmed, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233458 CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate) | Closure Medical Corp. | 1998 | 2 |
| −1 | K100423 | Dermabond NX Adhesive Model: DNX6, DNX12 | ETHICON, Inc. | 2010 | 1 |
| 0 (this device) | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini… | ETHICON, Inc. | 2015 | — |
| +1 | K243990 | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | 2025 | — |
| +1 | K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100423 | Dermabond NX Adhesive Model: DNX6, DNX12Summary page 5…Name: Tissue Adhesive for the Topical Approximation of Skin (21 CFR 878.4010) Product Code: MPN Predicate Device 510(k) Number DERMABOND ADVANCED™ Topical Skin Adhesive K100423 High Viscosity DERMABOND® Mini Topical Skin Adhesive P960052 510(k) Change Being Effected DERMABOND Advanced Topi… | 2010 |
| * | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Summary page 5…21 CFR 878.4010) Product Code: MPN Predicate Device 510(k) Number DERMABOND ADVANCED™ Topical Skin Adhesive K100423 High Viscosity DERMABOND® Mini Topical Skin Adhesive P960052 510(k) Change Being Effected DERMABOND Advanced Topical Skin Adhesive K152096 And DERMABOND Mini Topical Skin Ad… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-0953-2021 | Packaging process control | Product 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K243990 (Optmed, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K100423.
How does its category compare?
All MPN devicesMPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MPN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPN
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPN
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPN
244in 2025
MAUDE reports naming product code MPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 56 |
| 2008 | 1 | — | 0 | 32 |
| 2009 | 1 | — | 0 | 22 |
| 2010 | 3 | 77 | 0 | 21 |
| 2011 | 2 | — | 0 | 93 |
| 2012 | 2 | — | 0 | 135 |
| 2013 | 6 | 193 | 0 | 177 |
| 2014 | 4 | 96 | 0 | 199 |
| 2015 | 4 | 141 | 0 | 179 |
| 2016 | 5 | 173 | 0 | 194 |
| 2017 | 0 | — | 0 | 182 |
| 2018 | 0 | — | 0 | 272 |
| 2019 | 0 | — | 0 | 427 |
| 2020 | 2 | — | 0 | 225 |
| 2021 | 1 | — | 1 | 141 |
| 2022 | 0 | — | 0 | 165 |
| 2023 | 0 | — | 0 | 130 |
| 2024 | 3 | 266 | 0 | 236 |
| 2025 | 2 | — | 0 | 244 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DERMABOND ADVANCED™ 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 ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches. High viscosity DERMABOND® Adhesive is intended for topical application only to hold…
Read the full statement (102 words)
DERMABOND ADVANCED™ 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 ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
High viscosity DERMABOND® Adhesive 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. High viscosity DERMABOND® Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152096: DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152096
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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