FDA product code · Gastroenterology and urology
Dilator, Esophageal
FDA lists KNQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 40 FDA decisions since 1981. 20 recalls name this code, 0 of them Class I. The most-cited predicate is K993720, named by 2 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of KNQ 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 · KNQ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KNQ
121in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNQ
14in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNQ
282in 2025
MAUDE reports naming product code KNQ, 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 | — | 14 | 22 |
| 2008 | 0 | — | 0 | 128 |
| 2009 | 3 | 121 | 0 | 391 |
| 2010 | 0 | — | 0 | 176 |
| 2011 | 0 | — | 0 | 251 |
| 2012 | 1 | — | 0 | 251 |
| 2013 | 0 | — | 0 | 228 |
| 2014 | 0 | — | 0 | 164 |
| 2015 | 0 | — | 0 | 204 |
| 2016 | 0 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 231 |
| 2018 | 0 | — | 0 | 396 |
| 2019 | 0 | — | 0 | 388 |
| 2020 | 0 | — | 0 | 364 |
| 2021 | 0 | — | 0 | 351 |
| 2022 | 0 | — | 0 | 274 |
| 2023 | 0 | — | 0 | 319 |
| 2024 | 0 | — | 0 | 268 |
| 2025 | 0 | — | 0 | 282 |
| 2026 | 0 | — | 4 | — |
Planning a device in KNQ? 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) ReportRelated product codes
Other codes under 21 CFR 876.5365.