510(k) · Cleared
ClearedExpanSure Transseptal Dilation System
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 Mar 21, 2019 as substantially equivalent to K102948 (Baylis Medical Co., Inc., 2011) after a 232-day review. Its family tree reaches back 2 generations to 2002. 1 of the 8 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 21, 2019
- Review
- 232 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013919 (2002). 5 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- 1 generation backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- This deviceK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK241720 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK251325 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK233647 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2023
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheathdirect predicate · 2011
Most influential descendants
Showing 5 of 5 · See all- K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020 · cites it directly4descendants
- K220414VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022 · 2 generations on3descendants
- K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024 · 3 generations on1descendant
- K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2025 · 4 generations on0descendants
- K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| −1 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| 0 (this device) | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| +1 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| +2 | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| +3 | K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024 | — |
| +4 | K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025 | — |
| +3 | K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K102948 | Torflex Transseptal Guiding SheathSummary page 4…ntification of Legally Marketed Device Table 8.1: Predicate Device Predicate Manufacturer 510(k) Indications for Use Device TorFlex™ Baylis Medical K102948 The TorFlex Transseptal Guiding Transseptal Company Inc. Sheath is used for the percutaneous Guiding… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201288 | ExpanSure Large Access Transseptal Dilator | 2020 | 4 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201288 (Baylis Medical Company, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K102948.
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. 2019, 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 ExpanSure Transseptal Dilation System 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/K182064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182064: ExpanSure Transseptal Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182064
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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