510(k) · Cleared
ClearedFlexTract Deflectable-Rotational Dilator Sheath Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Jul 27, 2026 as substantially equivalent to K141148 (Cook Vascular, Inc., 2014) after a 97-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jul 27, 2026
- Review
- 97 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061000 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- 1 generation backK141148 Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution…Cook Vascular, Inc. · 2014
- This deviceK261310 FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| −1 | K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL… | Cook Vascular, Inc. | 2014 | — |
| 0 (this device) | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026 | — |
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 K241720 VersaCross Connect™ Transseptal Dilatorscore 11.9 · 5 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 |
|---|---|---|---|
| * | K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL…Summary page 5…olled-Rotation Dilator Sheath Set Classification Name: Dilator, Vessel, for Percutaneous Catheterization Predicate Premarket Notification: K141148 (submitted by Cook Vascular Inc.) Device Manufacturer: Merit Medical Systems, Inc.* * In 2… | 2014 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K141148.
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. 2026, 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 FlexTract Sheath Set is indicated for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261310: FlexTract Deflectable-Rotational 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/K261310
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026