510(k) · Cleared
ClearedSureflex Steerable Guiding Sheath Kit
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 Jan 24, 2013 after a 122-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Jan 24, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 2 citing it directly.
- This deviceK122926 Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
- Descendant · cites it directly · 1 of its ownK190688 VersaCross Steerable Sheath, VersaCross Transseptal DilatorBaylis Medical Company, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex…Innovative Health, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122926 | Sureflex Steerable Guiding Sheath Kit | Baylis Medical Co., Inc. | 2013 | — |
| +1 | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | 2019 | — |
| +1 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable… | Innovative Health, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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.
Planning a device in DYB? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K061633 | Agilis NxT Steerable Introducer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190688 (Baylis Medical Company, Inc., 2019) 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. 2013, 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 SureFlexTM Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122926: Sureflex Steerable Guiding Sheath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122926
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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