FDA product code · Orthopedic
Reherniation Reduction Device
1 FDA decision since 2019. No recall names this code.
The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QES 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 · QES
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QES
Too few QES 510(k)s in any year since 2007 to give a median.
Recalls per year · QES
No recall names QES since 2007.
Adverse event reports per year · QES
38in 2025
MAUDE reports naming product code QES, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 3 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 0 | 22 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 2 | — | 0 | 23 |
| 2025 | 2 | — | 0 | 38 |
| 2026 | 1 | — | 0 | — |
Planning a device in QES? 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