510(k) · Cleared
ClearedHansen Medical Transseptal Needle and Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DRC Trocar
Cleared on Oct 13, 2006 as substantially equivalent to K011727 (Thomas Medical Products, Inc., 2002) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Oct 13, 2006
- Review
- 179 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932619 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932619 Transseptal Introducer SetThomas Medical Products, Inc. · 1993
- 1 generation backK020090 Modification to Transseptal Introducer SetThomas Medical Products, Inc. · 2002
- This deviceK061070 Hansen Medical Transseptal Needle and DilatorHansen Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK082075 Hansen Medical Dilator for Artisan Control CatheterHansen Medical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082075Hansen Medical Dilator for Artisan Control CatheterHansen Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932619 | Transseptal Introducer Set | Thomas Medical Products, Inc. | 1993 | — |
| −1 | K020090 | Modification to Transseptal Introducer Set | Thomas Medical Products, Inc. | 2002 | — |
| 0 (this device) | K061070 | Hansen Medical Transseptal Needle and Dilator | Hansen Medical, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 DRC? 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 DRC device
- #1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K011727 | Transseptal Needle/TrocarSummary page 1…nt inintended use and method of operation to: 1. Daig Corp., BRK Transseptal Needle, pre-amendment. 2. Thomas Medical Products, Inc., Transseptal Needle/Trocar, K01 1727. 3. Thomas Medical Products, Inc., Catheter Introducer Set, K020090 - Vessel Dilator part of the set. Device Descript… | 2002 |
| * | K020090 | Modification to Transseptal Introducer SetSummary page 1…nsseptal Needle, pre-amendment. 2. Thomas Medical Products, Inc., Transseptal Needle/Trocar, K01 1727. 3. Thomas Medical Products, Inc., Catheter Introducer Set, K020090 - Vessel Dilator part of the set. Device Description: The Hansen Medical Transseptal Needle consists of an outer needle c… | 2002 |
| * | — | Daig Corp., BRK Transseptal Needle Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082075 | Hansen Medical Dilator for Artisan Control Catheter | 2008 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K082075 (Hansen Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011727.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRC
Too few DRC 510(k)s in any year since 2007 to give a median.
Recalls per year · DRC
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRC
69in 2025
MAUDE reports naming product code DRC, 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 | 1 | — | 0 | 106 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 17 |
| 2010 | 0 | — | 1 | 33 |
| 2011 | 1 | — | 0 | 68 |
| 2012 | 1 | — | 0 | 58 |
| 2013 | 1 | — | 1 | 37 |
| 2014 | 2 | — | 1 | 65 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 62 |
| 2017 | 2 | — | 0 | 70 |
| 2018 | 2 | — | 0 | 85 |
| 2019 | 0 | — | 1 (1) | 95 |
| 2020 | 0 | — | 0 | 108 |
| 2021 | 1 | — | 1 | 78 |
| 2022 | 2 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 109 |
| 2024 | 2 | — | 0 | 105 |
| 2025 | 0 | — | 0 | 69 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the 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/K061070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061070: Hansen Medical Transseptal Needle and Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061070
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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