510(k) · Cleared
ClearedPathBuilder Transseptal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Microport EP Medtech Co., Ltd. · DRC Trocar
Cleared on Mar 23, 2022 as substantially equivalent to K122587 (St Jude Medical, 2013) after a 217-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Mar 23, 2022
- Review
- 217 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964518 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 5 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 4 generations backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- 3 generations backK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
- 2 generations backK072278 BRK Transseptal NeedleSt Jude Medical · 2007
- 1 generation backK122587 BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207…St Jude Medical · 2013
- This deviceK212625 PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −5 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −4 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| −3 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
| −2 | K072278 | BRK Transseptal Needle | St Jude Medical | 2007 | — |
| −1 | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208Summary page 5…25 Identification of Predicate Device A. Product Name: BRKTM Transseptal Needle B. Manufacturer: St. Jude Medical C. 510(k) Number: K122587 D. Regulation Number 21 CFR 870.1390 E. Product Code: DRC F. Device Class: Class II Non-Clini… | 2013 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K122587.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 PathBuilder 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/K212625 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212625: PathBuilder 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/K212625
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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