510(k) · Cleared
ClearedExofin High Viscosity Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemence Medical, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Dec 17, 2020 as substantially equivalent to K152476 (Chemence Medical Products, Inc., 2016) after a 318-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Dec 17, 2020
- Review
- 318 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P960052 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP960052 Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 1998 · Recalled
- 2 generations backK100423 Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc. · 2010 · Recalled
- 1 generation backK152476 Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016
- This deviceK200264 Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK212246 Exofin Precision PenChemence Medical, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212246Exofin Precision PenChemence Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate) | Closure Medical Corp. | 1998 | 2 |
| −2 | K100423 | Dermabond NX Adhesive Model: DNX6, DNX12 | ETHICON, Inc. | 2010 | 1 |
| −1 | K152476 | Exofin High Viscosity Tissue Adhesive | Chemence Medical Products, Inc. | 2016 | — |
| 0 (this device) | K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical, Inc. | 2020 | — |
| +1 | K212246 | Exofin Precision Pen | Chemence Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K152476 | Exofin High Viscosity Tissue AdhesiveSummary page 4…e Legally marketed devices to which equivalence is claimed: Device Name: Exofin® High Viscosity Tissue Adhesive 510(k) Clearance: K152476 K200264… | 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 |
|---|---|---|---|
| K212246 | Exofin Precision Pen | 2021 | 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 22 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K212246 (Chemence Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
Exofin® High Viscosity 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.
Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200264: Exofin High Viscosity 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/K200264
Report an extraction error
Are you the manufacturer?
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