510(k) · Cleared
ClearedBRK Transseptal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DRC Trocar
Cleared on Sep 13, 2007 as substantially equivalent to K011727 (Thomas Medical Products, Inc., 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1997. 8 later devices descend from it.
- Decided
- Sep 13, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964518 (1997). 6 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 2 generations backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- 1 generation backK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
- This deviceK072278 BRK Transseptal NeedleSt Jude Medical · 2007
- Descendant · cites it directly · 6 of its ownK122587 BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207…St Jude Medical · 2013
- Descendant · 2 generations on · 1 of its ownK172950 TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC · 2018
- Descendant · 2 generations on · 1 of its ownK172934 Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK212625 PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical · 2013 · cites it directly6descendants
- K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC · 2018 · 2 generations on1descendant
- K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC · 2018 · 2 generations on1descendant
- K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024 · 3 generations on0descendants
- K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −3 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −2 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| −1 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
| 0 (this device) | K072278 | BRK Transseptal Needle | St Jude Medical | 2007 | — |
| +1 | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013 | — |
| +2 | K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | 2018 | — |
| +2 | K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | 2018 | — |
| +3 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | 2024 | — |
| +2 | K212625 | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K011727 | Transseptal Needle/Trocar | 2002 |
| * | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…Summary page 1…t Code DRC Predicate Device: 1. Thomas Medical Products, Inc., Transseptal Needle/Trocar (KOI 1727) 2. St. Jude Medical ACrossTMTransseptal Access System (K070417) Device Description: The St. Jude Medical Transseptal Needle consists of a luminal stainless steel needle and solid stainless… | 2007 |
What descends from it? (8)
3 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K122587 (St Jude Medical, 2013) has gone furthest, with 6 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. 2007, this device’s year, is highlighted.
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 St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072278: BRK Transseptal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072278
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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