510(k) · Cleared
ClearedCM005 Standard (CM005); CM004 Mini (CM004)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Connexicon Medical, Ltd. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Jul 15, 2024 as substantially equivalent to K152096 (ETHICON, Inc., 2015) after a 266-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 15, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P960052 (1998). No later device cites it as a predicate yet.
- 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 backK152096 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND…ETHICON, Inc. · 2015 · Recalled
- This deviceK233458 CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd. · 2024
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 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini… | ETHICON, Inc. | 2015 | 1 |
| 0 (this device) | K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…Summary page 5…e and High Viscosity DERMABOND® Mini Topical Skin Adhesive 510(k) Clearance: K152096 Device Description CM005 Standard CM005 Standard Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K152096.
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. 2024, 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?
The indication for use for both devices is shown below: CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD…
Read the full statement (146 words)
The indication for use for both devices is shown below:
CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.
CMOO4 Mini Topical Skin Adhesive is indicated 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233458 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233458: CM005 Standard (CM005); CM004 Mini (CM004).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233458
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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