510(k) · Cleared
Recalled · Class I · 2019Torflex Transseptal Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · DYB Introducer, Catheter
Cleared on Apr 1, 2011 as substantially equivalent to K013919 (Baylis Medical Co., Inc., 2002) after a 178-day review. Its family tree reaches back 1 generation to 2002. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Apr 1, 2011
- Review
- 178 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013919 (2002). 9 later devices descend from it, 2 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- This deviceK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011
- Descendant · cites it directly · 5 of its ownK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK183655 VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 1 of its ownK241720 VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182064ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019 · cites it directly5descendants
- K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020 · 2 generations on4descendants
- K220414VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022 · 3 generations on3descendants
- K183655VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019 · cites it directly2descendants
- K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| 0 (this device) | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | — |
| +1 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| +2 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| +3 | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| +1 | K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | 2019 | 3 |
| +4 | K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K013919 | Torflex Transseptal Guiding SheathSummary page 1…3) DOY Identification of Predicate Device The predicate device is the TorFlexTM Transseptal Guiding Sheath, which is cleared under 510(k) Premarket Notification Number K01 3919. Modifications to the current device include changes to the sheath design and materials, kit packaging, and device manufacturer a… | 2002 |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2019 | Class II | Z-2069-2020 | Package design/selection | There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient… |
| Oct 7, 2019 | Class II | Z-2070-2020 | Package design/selection | There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may… |
| Sep 23, 2013 | Class I | Z-0085-2014 | Component design/selection | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K182064 (Baylis Medical Company, Inc., 2019) has gone furthest, with 5 descendants 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. 2011, 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 TorFlexTM Transseptal Guiding Sheath is used for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102948: Torflex Transseptal Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102948
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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