510(k) · Cleared
ClearedVersaCross Connect™ Transseptal Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on May 29, 2025 as substantially equivalent to K241720 (Baylis Medical Company, Inc., 2024) after a 30-day review. Its family tree reaches back 6 generations to 2002. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- May 29, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013919 (2002). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- 5 generations backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- 4 generations backK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- 3 generations backK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- 2 generations backK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- 1 generation backK241720 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024
- This deviceK251325 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheath5 generations back · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| −5 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| −4 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| −3 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| −2 | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| −1 | K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024 | — |
| 0 (this device) | K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025 | — |
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.
1 device in this family has a Class I recall. 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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 |
|---|---|---|---|
| * | K241720 | VersaCross Connect™ Transseptal DilatorSummary page 6…saCross Transseptal Dilator is indicated Connect™ Baylis Medical K241720 for use in procedures where Transseptal Company Inc. access to the l… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251325: VersaCross Connect™ Transseptal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251325
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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