510(k) · Cleared
ClearedOptical DVS (Dual Vector Shearing) Esophageal Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · KNQ Dilator, Esophageal
Cleared on Jan 12, 2004 as substantially equivalent to K851955 (Wilson-Cook Medical, Inc., 1985) after a 277-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Jan 12, 2004
- Review
- 277 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851955 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851955 Savary-Gilliard DilatorWilson-Cook Medical, Inc. · 1985 · Recalled
- This deviceK031147 Optical DVS (Dual Vector Shearing) Esophageal DilatorEthicon Endo-Surgery, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK093236 Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK082995 Smart DilatorSafestitch Medical · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851955 | Savary-Gilliard Dilator | Wilson-Cook Medical, Inc. | 1985 | 1 |
| 0 (this device) | K031147 | Optical DVS (Dual Vector Shearing) Esophageal Dilator | Ethicon Endo-Surgery, Inc. | 2004 | — |
| +1 | K093236 | Ethicon Endo-Surgeryoptical Dilator | Ethicon Endo-Surgery, Inc. | 2009 | — |
| +1 | K082995 | Smart Dilator | Safestitch Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | K851955 | Savary-Gilliard DilatorSummary page 1…e Name: Optical DVS (Dual Vector Shearing) Esophageal Dilator Classification Name: Esophageal Dilator Predicate Devices: Savary-Gilliard Dilators cleared under K851955 on 07/25/85 Device Description The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031147: Optical DVS (Dual Vector Shearing) Esophageal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031147
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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