510(k) · Cleared
ClearedTightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
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 Dec 15, 2022 as substantially equivalent to K212784 (Spectranetics, Inc., 2022) after a 28-day review. Its family tree reaches back 7 generations to 2006.
- Decided
- Dec 15, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K061000 (2006). No later device cites it as a predicate yet.
- Root · 7 generations backK061000 Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0Cook Vascular, Inc. · 2006
- 6 generations backK140047 Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp. · 2014
- 5 generations backK141131 Tightrail MiniSpectranetics, Inc. · 2014
- 4 generations backK142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc. · 2014
- 3 generations backK150360 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator…Spectranetics, Inc. · 2015
- 2 generations backK161333 TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. · 2016
- 1 generation backK212784 TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. · 2022
- This deviceK223472 TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)…Spectranetics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K061000 | Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 | Cook Vascular, Inc. | 2006 | — |
| −6 | K140047 | Lexiconture Mechanical Dilator Sheath Set | Spectranetics Corp. | 2014 | — |
| −5 | K141131 | Tightrail Mini | Spectranetics, Inc. | 2014 | — |
| −4 | 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 | — |
| −2 | K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016 | — |
| −1 | K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022 | — |
| 0 (this device) | K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail… | Spectranetics, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K212784 | TightRail Guardian Motorized Dilator SheathSummary page 4…ilator Sheath is being compared to the following legally marketed predicate devices: TightRail Guardian Motorized Dilator Sheath 510(k) Number: K212784 (cleared 24 August 2022) Manufacturer: The Spectranetics Corporation Trade Name:… | 2022 |
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 16 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- None of the 7 ancestors has a recall.
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. 2022, 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 Guardian motorized dilator sheath is intended for use in patients requiring the
percutaneous dilation of tissue to facilitate removal of cardiac leads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223472: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223472
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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