FDA product code · General and plastic surgery
Cutaneous Tissue Adhesive With Mesh
9 FDA decisions since 2010. 510(k) reviews decided 2021–2025 took a median of 266 days (half between 151 and 301). No recall names this code. The most-cited predicate is K133864, named by 6 later devices.
For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OMD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in OMD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report