510(k) · Cleared
ClearedExofin Fusion Skin Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemence Medical, Inc. · OMD Cutaneous Tissue Adhesive With Mesh
Cleared on Jun 5, 2020 as substantially equivalent to K171442 (Chemence Medical, Inc., 2017) after a 368-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it.
- Decided
- Jun 5, 2020
- Review
- 368 days
- Class
- Class II
- Product code
- OMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN090005 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN090005 Prineo Skin Closure SystemClosure Medical Corp. · 2010
- 2 generations backK133864 Dermabond Prineo Skin Closure SystemETHICON, Inc. · 2014 · Recalled
- 1 generation backK171442 Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2017
- This deviceK191461 Exofin Fusion Skin Closure SystemChemence Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK211878 LiquiBand XLAdvanced Medical Solutions Limited · 2022
Most influential descendants
Showing 1 of 1 · See all- K211878LiquiBand XLAdvanced Medical Solutions Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN090005 | Prineo Skin Closure System | Closure Medical Corp. | 2010 | — |
| −2 | K133864 | Dermabond Prineo Skin Closure System | ETHICON, Inc. | 2014 | 1 |
| −1 | K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2017 | — |
| 0 (this device) | K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2020 | — |
| +1 | K211878 | LiquiBand XL | Advanced Medical Solutions Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 K233460 CM00622 LINC Skin Closure System (CM00622 LINC)score 8.0 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171442 | Exofin Fusion Skin Closure SystemSummary page 5…component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive. Predicate Devices: K171442 Exofin® Fusion Skin Closure System Reference Device: K152476 Exofin® High Viscosity Tissue Adhesive Comparis… | 2017 |
| † | K152476 | Exofin High Viscosity Tissue Adhesive | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211878 | LiquiBand XL | 2022 | 0 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K211878 (Advanced Medical Solutions Limited, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OMD devicesOMD Cutaneous Tissue Adhesive With Mesh: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OMD
1in 2024
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
MAUDE reports naming product code OMD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 54 |
| 2014 | 1 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 94 |
| 2016 | 0 | — | 0 | 125 |
| 2017 | 2 | — | 0 | 163 |
| 2018 | 0 | — | 0 | 206 |
| 2019 | 0 | — | 0 | 153 |
| 2020 | 1 | — | 0 | 86 |
| 2021 | 1 | — | 0 | 186 |
| 2022 | 1 | — | 0 | 175 |
| 2023 | 0 | — | 0 | 171 |
| 2024 | 1 | — | 0 | 256 |
| 2025 | 0 | — | 0 | 288 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Exofin Fusion Skin Closure System 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. Exofin Fusion Skin Closure System 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.
https://510kreport.com/device/K191461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191461: Exofin Fusion Skin Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191461
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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