510(k) · Cleared
ClearedTSP Crosser Transseptal Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transseptal Solutions, Ltd. · DYB Introducer, Catheter
Cleared on Sep 28, 2018 as substantially equivalent to K070417 (St Jude Medical, 2007) after a 156-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 28, 2018
- Review
- 156 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964518 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK181088 TSP Crosser Transseptal Access SystemTransseptal Solutions, Ltd. · 2018
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) | K181088 | TSP Crosser Transseptal Access System | Transseptal Solutions, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…Summary page 4…Division of Cardiovascular Devices 6.3 Predicate Device Primary Predicate Name St. Jude ACrossTM Transseptal Access System (K070417) and 510(k) Number: Reference Device: St. Jude AgilisTM NxT Steerable Introducer (K081645) 6.4 Device Descri… | 2007 |
| † | K081645 | Agilis NXT Steerable Introducer, Model G408324 | 2008 |
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 21 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K070417.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181088: TSP Crosser Transseptal Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181088
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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