510(k) · Cleared
ClearedDERMABOND PRINEO Skin Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · OMD Cutaneous Tissue Adhesive With Mesh
Cleared on Nov 25, 2015 as substantially equivalent to DEN090005 (Closure Medical Corp., 2010) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Nov 25, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- OMD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to DEN090005 (2010). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (3)
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 |
|---|---|---|---|
| * | DEN090005 | Prineo Skin Closure System Our OCR of the scanned summary read K082289, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090005, Prineo Skin Closure System (Closure Medical Corp.), granted Apr 30, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2010 |
| * | DEN090005 | Prineo Skin Closure SystemSummary page 4…sure device intended for topical approximation of skin (21 CFR 878.4011) Product Code: OMD Predicate Device 510(k) Number DERMABOND™ PRINEO™ Skin Closure System K082289/DEN090005 DERMABOND™ PRINEO™ Skin Closure System K133864 Ethicon, Inc. 510(k) Change Being Effected DERMABOND™ PRINEO™ Skin… | 2010 |
| * | K133864 | Dermabond Prineo Skin Closure SystemSummary page 4…skin (21 CFR 878.4011) Product Code: OMD Predicate Device 510(k) Number DERMABOND™ PRINEO™ Skin Closure System K082289/DEN090005 DERMABOND™ PRINEO™ Skin Closure System K133864 Ethicon, Inc. 510(k) Change Being Effected DERMABOND™ PRINEO™ Skin Closure System Device Description: DERMABOND… | 2014 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate DEN090005.
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. 2015, 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?
DERMABOND™ PRINEO™ System 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. DERMABOND™ PRINEO™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152490: DERMABOND PRINEO 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/K152490
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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