510(k) · Cleared
ClearedHansen Medical Dilator for Artisan Control Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Aug 15, 2008 as substantially equivalent to K061070 (Hansen Medical, Inc., 2006) after a 23-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Aug 15, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932619 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK932619 Transseptal Introducer SetThomas Medical Products, Inc. · 1993
- 2 generations backK020090 Modification to Transseptal Introducer SetThomas Medical Products, Inc. · 2002
- 1 generation backK061070 Hansen Medical Transseptal Needle and DilatorHansen Medical, Inc. · 2006
- This deviceK082075 Hansen Medical Dilator for Artisan Control CatheterHansen Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932619 | Transseptal Introducer Set | Thomas Medical Products, Inc. | 1993 | — |
| −2 | K020090 | Modification to Transseptal Introducer Set | Thomas Medical Products, Inc. | 2002 | — |
| −1 | K061070 | Hansen Medical Transseptal Needle and Dilator | Hansen Medical, Inc. | 2006 | — |
| 0 (this device) | K082075 | Hansen Medical Dilator for Artisan Control Catheter | Hansen Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K061070 | Hansen Medical Transseptal Needle and DilatorSummary page 1…or Artisan Control Catheter Classification name: Vessel Dilator (21 CFR 870.1310, Product Code DRE) Predicate Devices: Hansen Medical Transseptal Needle and Dilator (K061070). Device Description: The Dilator for Artisan Control Catheter is made of a flexible tube with a tapered end on the distal out… | 2006 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2008, 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 Dilator for ArtisanTM Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082075 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082075: Hansen Medical Dilator for Artisan Control Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082075
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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