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. · DYB Introducer, Catheter
Cleared on May 9, 2022 as substantially equivalent to K201288 (Baylis Medical Company, Inc., 2020) after an 84-day review. Its family tree reaches back 4 generations to 2002. 1 of the 8 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 9, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013919 (2002). 3 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- 3 generations backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- 2 generations backK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- 1 generation backK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- This deviceK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK241720 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251325 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233647 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2023
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheath3 generations back · 2011
Most influential descendants
Showing 3 of 3 · See all- K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024 · cites it directly1descendant
- K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025 · 2 generations on0descendants
- K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| −3 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| −2 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| −1 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| 0 (this device) | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| +1 | K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024 | — |
| +2 | K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025 | — |
| +1 | K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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 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 |
|---|---|---|---|
| * | K201288 | ExpanSure Large Access Transseptal DilatorSummary page 4…keted Device Table 13.1: Predicate Device Predicate Device Manufacturer 510(k) Indications for Use ExpanSure™ Large Baylis Medical K201288 The ExpanSure Large Access Access Transseptal Company Inc. Transseptal Dilator is indicated for Dilator… | 2020 |
| † | K183655 | VersaCross Transseptal Sheath | 2019 |
| † | K161878 | PORTAGE System | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241720 (Baylis Medical Company, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 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/K220414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220414: 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/K220414
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