FDA product code · Ear, nose and throat
Tympanostomy Tube Delivery Product With Drug
1 FDA decision since 2019. No recall names this code.
Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QJA 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 · QJA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJA
Too few QJA 510(k)s in any year since 2007 to give a median.
Recalls per year · QJA
No recall names QJA since 2007.
Adverse event reports per year · QJA
6in 2025
MAUDE reports naming product code QJA, 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 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
Planning a device in QJA? 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