510(k) · Cleared
Recalled · 2011Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cryocath, LP · DRA Catheter, Steerable
Cleared on Sep 1, 2010 as substantially equivalent to K081049 (Cryocath Technologies, Inc., 2008) after a 29-day review. Its family tree reaches back 2 generations to 2007. 2 of the 26 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- DRA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070357 (2007). 23 later devices descend from it, 3 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 1 generation backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- This deviceK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010
- Descendant · cites it directly · 13 of its ownK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- Descendant · cites it directly · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 4 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012 · cites it directly13descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · cites it directly7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 2 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 3 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −1 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| 0 (this device) | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | — |
| +1 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| +1 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +2 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +3 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +4 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
2 devices in this family have 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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 |
|---|---|---|---|
| * | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Summary page 1…1280 Product Code: DRA Predicate Device(s): The subject device is equivalent to the following devices: K081049 - FlexCath Steerable Sheath & Dilator, Models 3FClO, 3FC12 Device Description:… | 2008 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2011 | Not classified | Z-3186-2011 | Pending | Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood and saline solution leaking out of, and… |
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.
- K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123591 (Medtronic Cryocath, LP, 2012) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K081049.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102176
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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