510(k) · Cleared
ClearedTightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Sep 25, 2014 as substantially equivalent to K140047 (Spectranetics Corp., 2014) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 2006. 5 later devices descend from it.
- Decided
- Sep 25, 2014
- Review
- 15 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K061000 (2006). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- 2 generations backK140047 Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014
- 1 generation backK141131 Tightrail MiniSpectranetics, Inc. · 2014
- This deviceK142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK150360 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator…Spectranetics, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK161333 TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK212784 TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK223472 TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)…Spectranetics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211679 Xtractor deviceXcardia Innovation, Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc. · 2015 · cites it directly3descendants
- K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016 · cites it directly2descendants
- K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022 · 2 generations on1descendant
- K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc. · 2022 · 3 generations on0descendants
- K211679Xtractor deviceXcardia Innovation, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| −2 | K140047 | Lexiconture Mechanical Dilator Sheath Set | Spectranetics Corp. | 2014 | — |
| −1 | K141131 | Tightrail Mini | Spectranetics, Inc. | 2014 | — |
| 0 (this device) | K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath | Spectranetics, Inc. | 2014 | — |
| +1 | K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | 2015 | — |
| +1 | K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016 | — |
| +2 | K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022 | — |
| +3 | K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail… | Spectranetics, Inc. | 2022 | — |
| +1 | K211679 | Xtractor device | Xcardia Innovation, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 3 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140047 | Lexiconture Mechanical Dilator Sheath SetSummary page 4…icate Device The TightRail and TightRail Mini Rotating Dilator Sheaths were compared to the following legally marketed predicate devices: 510(k) Number: K140047 (cleared 9 April 2014) K141131 (cleared 23 May 2014) Manufacturer: Spectranetics… | 2014 |
| * | K141131 | Tightrail MiniSummary page 4…Sheaths were compared to the following legally marketed predicate devices: 510(k) Number: K140047 (cleared 9 April 2014) K141131 (cleared 23 May 2014) Manufacturer: Spectranetics Trade Name: TightRail and TightRail Mini Ro… | 2014 |
What descends from it? (5)
3 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150360 (Spectranetics, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K140047.
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 TightRail and TightRail Mini Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142546: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142546
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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