510(k) · Cleared
ClearedJackson Esophageal Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pilling Weck Surgical · KNQ Dilator, Esophageal
Cleared on May 17, 1999 after a 59-day review. The FDA summary names its predicate without a number.
- Decided
- May 17, 1999
- Review
- 59 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Jackson Esophageal Dilator made with Cyanoacrylate Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KNQ devicesKNQ Dilator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
What is it indicated for?
To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990935: Jackson Esophageal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990935
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026