510(k) · Cleared
ClearedCri Cynosar Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Research C/O Burditt, Bowles & Radzius · DRA Catheter, Steerable
Cleared on Mar 6, 1991 after a 135-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 33 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it.
- Decided
- Mar 6, 1991
- Review
- 135 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 1 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- This deviceK904785 Cri Cynosar CatheterCatheter Research C/O Burditt, Bowles & Radzius · 1991
- Descendant · cites it directly · 31 of its ownK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 30 of its ownK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 28 of its ownK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- Descendant · 4 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- Descendant · 5 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 32 · See all- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · cites it directly31descendants
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 2 generations on30descendants
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations on28descendants
- K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 4 generations on24descendants
- K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904785 | Cri Cynosar Catheter | Catheter Research C/O Burditt, Bowles & Radzius | 1991 | — |
| +1 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| +2 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| +3 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| +4 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| +5 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 2 |
| 2006 | 1 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040922 | Venture Wire Control Catheter Class I | 2004 | 31 |
Has anything in its family been recalled? (3 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.
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040922 (Velocimed, Inc., 2004) has gone furthest, with 31 descendants of its own.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K904785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904785: Cri Cynosar Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904785
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026