510(k) · Cleared
ClearedCook Endoscopy Esophageal Dilation Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Endoscopy · KNQ Dilator, Esophageal
Cleared on Dec 1, 2006 as substantially equivalent to K935094 (Wilson-Cook Medical, Inc., 1995) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Dec 1, 2006
- Review
- 144 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935094 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK935094 Balloon Dilation CatheterWilson-Cook Medical, Inc. · 1995 · Recalled
- This deviceK061937 Cook Endoscopy Esophageal Dilation BalloonCook Endoscopy · 2006
- Descendant · cites it directly · 0 of its ownK080158 LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008
Most influential descendants
Showing 1 of 1 · See all- K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935094 | Balloon Dilation Catheter | Wilson-Cook Medical, Inc. | 1995 | 2 |
| 0 (this device) | K061937 | Cook Endoscopy Esophageal Dilation Balloon | Cook Endoscopy | 2006 | — |
| +1 | K080158 | LB Medical Inflatable Tissue Elevator/Expander System | Lb Medical LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
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? (2)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080158 | LB Medical Inflatable Tissue Elevator/Expander System | 2008 | 0 |
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.
What does this lineage say?
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?
The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061937: Cook Endoscopy Esophageal Dilation Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061937
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026