510(k) · Cleared
ClearedTightRail Sub-C Rotating 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 Jul 8, 2016 as substantially equivalent to K142546 (Spectranetics, Inc., 2014) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 2006. 2 later devices descend from it.
- Decided
- Jul 8, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K061000 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- 4 generations backK140047 Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014
- 3 generations backK141131 Tightrail MiniSpectranetics, Inc. · 2014
- 2 generations backK142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014
- 1 generation backK150360 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator…Spectranetics, Inc. · 2015
- This deviceK161333 TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK212784 TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223472 TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)…Spectranetics, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −5 | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| −4 | K140047 | Lexiconture Mechanical Dilator Sheath Set | Spectranetics Corp. | 2014 | — |
| −3 | K141131 | Tightrail Mini | Spectranetics, Inc. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016 | — |
| +1 | K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022 | — |
| +2 | K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail… | Spectranetics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSummary page 4…013 Predicate Device The TightRail Sub-C Rotating Dilator Sheaths were compared to the following legally marketed predicate devices: 510(k) Number: K142546 (cleared 25 September 2014) and K150360 (cleared 4 March 2015) Manufacturer: Spectranetics Trade Name:… | 2014 |
| * | K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSummary page 4…C Rotating Dilator Sheaths were compared to the following legally marketed predicate devices: 510(k) Number: K142546 (cleared 25 September 2014) and K150360 (cleared 4 March 2015) Manufacturer: Spectranetics Trade Name: TightRail and TightRail Mini Rotatin… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212784 | TightRail Guardian Motorized Dilator Sheath | 2022 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K212784 (Spectranetics, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K142546.
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. 2016, 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 Sub-C Rotating Dilator Sheath is 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 as stated in the FDA summary.
https://510kreport.com/device/K161333 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161333: TightRail Sub-C Rotating Dilator Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161333
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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