510(k) · Cleared
ClearedSafeCross Transseptal Puncture and Introducer (TSP/I) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
East End Medical I, LLC · DYB Introducer, Catheter
Cleared on Jul 6, 2021 as substantially equivalent to K081645 (St Jude Medical, 2008) and 1 other predicate after a 224-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 6, 2021
- Review
- 224 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964518 (1997). 9 ancestors in all. 2 later devices descend from it, 2 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 backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 1 generation backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- This deviceK203459 SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC · 2021
- Descendant · cites it directly · 0 of its ownK260839 Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK240600 SafeCross Vascular Introducer System (4001)East End Medical I, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −1 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| 0 (this device) | K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | 2021 | — |
| +1 | K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026 | — |
| +1 | K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 4…DXF, Catheter, Septostomy Panel: Cardiovascular 3. PREDICATE DEVICES Primary Predicate Device: Agilis NXT Steerable Introducer, K081645, St. Jude Medical Secondary Predicate Device: NRG Transseptal Needle, K073326, Baylis Medical Company, Inc. Reference Device: A… | 2008 |
| * | K073326 | NRG Transseptal NeedleSummary page 4…cular 3. PREDICATE DEVICES Primary Predicate Device: Agilis NXT Steerable Introducer, K081645, St. Jude Medical Secondary Predicate Device: NRG Transseptal Needle, K073326, Baylis Medical Company, Inc. Reference Device: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX, K193509, Acutus… | 2008 |
| † | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | 2020 |
What descends from it? (2)
2 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 24 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K260839 (Protaryx Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K081645.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203459: SafeCross Transseptal Puncture and Introducer (TSP/I) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203459
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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