510(k) · Cleared
ClearedSpectranetics Visisheath Dilator Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Nov 2, 2009 after an 89-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Nov 2, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK092378 Spectranetics Visisheath Dilator SheathSpectranetics Corp. · 2009
- Descendant · cites it directly · 2 of its ownK093554 Retroflex Dilator KitEdwards Lifesciences, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK123842 Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK170616 van Andel Dilatation CatheterCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK133631 Lexipliant Dilator Sheath SetSpectranetics Corporation · 2014
Most influential descendants
Showing 4 of 4 · See all- K093554Retroflex Dilator KitEdwards Lifesciences, LLC · 2010 · cites it directly2descendants
- K123842Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013 · 2 generations on1descendant
- K170616van Andel Dilatation CatheterCook Incorporated · 2017 · 3 generations on0descendants
- K133631Lexipliant Dilator Sheath SetSpectranetics Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092378 | Spectranetics Visisheath Dilator Sheath | Spectranetics Corp. | 2009 | — |
| +1 | K093554 | Retroflex Dilator Kit | Edwards Lifesciences, LLC | 2010 | — |
| +2 | K123842 | Lawmax Dilator | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013 | — |
| +3 | K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017 | — |
| +1 | K133631 | Lexipliant Dilator Sheath Set | Spectranetics Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K093554 (Edwards Lifesciences, LLC, 2010) has gone furthest, with 2 descendants of its own.
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. 2009, 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 VisiSheath Dilator Sheath is intended for Use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092378: Spectranetics Visisheath Dilator Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092378
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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