510(k) · Cleared
Recalled · 2010Torflex Transseptal Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · DBY Fab, Rhodamine, Antigen, Antiserum, Control
Cleared on Feb 22, 2002 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2002
- Review
- 87 days
- Class
- Class I
- Product code
- DBY
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002
- Descendant · cites it directly · 9 of its ownK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK182064 ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK201288 ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK220414 VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK183655 VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheathcites it directly · 2011
Most influential descendants
Showing 5 of 10 · See all- K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · cites it directly9descendants
- K182064ExpanSure Transseptal Dilation SystemBaylis Medical Company, Inc. · 2019 · 2 generations on5descendants
- K201288ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. · 2020 · 3 generations on4descendants
- K220414VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. · 2022 · 4 generations on3descendants
- K183655VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | — |
| +1 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| +2 | K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019 | — |
| +3 | K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020 | — |
| +4 | K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022 | — |
| +2 | K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | 2019 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 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 510(k) statement (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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102948 | Torflex Transseptal Guiding Sheath Class I | 2011 | 9 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2010 | Not classified | Z-0816-2010 | Component design/selection | Radiopaque soft tip may fracture. |
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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K102948 (Baylis Medical Co., Inc., 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DBY devicesDBY Fab, Rhodamine, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBY
FDA has decided no DBY device since 2007.
Median 510(k) review, days · DBY
Too few DBY 510(k)s in any year since 2007 to give a median.
Recalls per year · DBY
No recall names DBY since 2007.
Adverse event reports per year · DBY
1in 2007
MAUDE reports naming product code DBY, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TorFlex Transseptal Guiding Sheath is indicated for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture/perforation.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013919: 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/K013919
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026