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 Dec 14, 2023 as substantially equivalent to K220414 (Baylis Medical Company, Inc., 2022) after a 30-day review. Its family tree reaches back 5 generations to 2002. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 14, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K013919 (2002). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- 4 generations backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- 3 generations backK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- 2 generations backK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- 1 generation backK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- This deviceK233647 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2023
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheath4 generations back · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| −4 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| −3 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| −2 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| −1 | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| 0 (this device) | K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K220414 | VersaCross Connect Transseptal DilatorSummary page 5…e Table 13.1: Predicate Device Predicate Device Manufacturer 510(k) Indications for Use VersaCross Baylis Medical K220414 The VersaCross ConnectTM Connect™ Company Inc. Transseptal Dilator is indicated Transseptal… | 2022 |
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K220414.
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. 2023, 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/K233647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233647: 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/K233647
Report an extraction error
Are you the manufacturer?
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