510(k) · Cleared
ClearedEvolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set
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 Jul 1, 2014 as substantially equivalent to K061000 (Cook Vascular, Inc., 2006) after a 57-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Jul 1, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061000 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- This deviceK141148 Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution…Cook Vascular, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK261310 FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK142301 Evolution Mechanical Dilator Sheath Set, Evolution Shortie…Cook Vascular, Inc. · 2014
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 | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| 0 (this device) | K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL… | Cook Vascular, Inc. | 2014 | — |
| +1 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026 | — |
| +1 | K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator… | Cook Vascular, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (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 |
|---|---|---|---|
| * | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Summary page 1…0.13 10 Product Code: DRE Predicate Device: 0The predicate device is the Evolution® Mechanical Dilator Sheath Set (Cook Vascular, Inc., K061000). K141148 p.2 of 5 Coo… | 2006 |
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 DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tisue surrounding cardiac leads, indwelling catheters and foreign objects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141148: Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141148
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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