510(k) · Cleared
ClearedEvolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Vascular, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on May 10, 2006 after a 29-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK140047 Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014
- Descendant · 2 generations on · 6 of its ownK141131 Tightrail MiniSpectranetics, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK150360 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator…Spectranetics, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK161333 TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K140047Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014 · cites it directly7descendants
- K141131Tightrail MiniSpectranetics, Inc. · 2014 · 2 generations on6descendants
- K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014 · 2 generations on5descendants
- K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc. · 2015 · 3 generations on3descendants
- K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| +1 | K140047 | Lexiconture Mechanical Dilator Sheath Set | Spectranetics Corp. | 2014 | — |
| +2 | K141131 | Tightrail Mini | Spectranetics, Inc. | 2014 | — |
| +2 | K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath | Spectranetics, Inc. | 2014 | — |
| +3 | K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | 2015 | — |
| +3 | K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 3 | 0 |
| 2026 | 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 DRE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 113 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?
- Of its descendants, K140047 (Spectranetics Corp., 2014) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous
dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061000
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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