FDA product code · Neurology
Sealant, Dural
5 FDA decisions since 2005. No recall names this code.
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NQR 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 · NQR
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQR
Too few NQR 510(k)s in any year since 2007 to give a median.
Recalls per year · NQR
No recall names NQR since 2007.
Adverse event reports per year · NQR
54in 2025
MAUDE reports naming product code NQR, 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 | 2 | — | 0 | 52 |
| 2008 | 0 | — | 0 | 23 |
| 2009 | 7 | — | 0 | 6 |
| 2010 | 3 | — | 0 | 11 |
| 2011 | 6 | — | 0 | 33 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 2 | — | 0 | 36 |
| 2014 | 3 | — | 0 | 26 |
| 2015 | 2 | — | 0 | 21 |
| 2016 | 4 | — | 0 | 23 |
| 2017 | 2 | — | 0 | 29 |
| 2018 | 6 | — | 0 | 45 |
| 2019 | 3 | — | 0 | 37 |
| 2020 | 10 | — | 0 | 24 |
| 2021 | 6 | — | 0 | 20 |
| 2022 | 4 | — | 0 | 39 |
| 2023 | 15 | — | 0 | 19 |
| 2024 | 3 | — | 0 | 20 |
| 2025 | 13 | — | 0 | 54 |
| 2026 | 10 | — | 0 | — |
Planning a device in NQR? 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