510(k) · Cleared
ClearedSidekick and Usher Support Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 2, 2013 as substantially equivalent to K073289 (Flowcardia, Inc., 2008) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 2, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953987 (1995). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
- 2 generations backK972484 Acs Viking Guiding CatheterGuidant Corp. · 1997 · Recalled
- 1 generation backK073289 Microsheath XL CathetersFlowcardia, Inc. · 2008
- This deviceK131493 Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK161986 SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203275 Recon Support CatheterC.R. Bard, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −3 | K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| −2 | K972484 | Acs Viking Guiding Catheter | Guidant Corp. | 1997 | 2 |
| −1 | K073289 | Microsheath XL Catheters | Flowcardia, Inc. | 2008 | — |
| 0 (this device) | K131493 | Sidekick and Usher Support Catheters | C.R. Bard, Inc. | 2013 | — |
| +1 | K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | 2016 | — |
| +1 | K203275 | Recon Support Catheter | C.R. Bard, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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? (2)
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 |
|---|---|---|---|
| * | K073289 | Microsheath XL CathetersSummary page 1…Code DOY) Classification: Class 11 Classification Panel: Cardiovascular Predicate Devices: " MicroSheath XL Support Catheter (K073289; cleared January 11, 2008) * MicroSheath LP Support Catheter (K080849; cleared July 25, 2008) Bard Peripheral Vascular, I… | 2008 |
| * | K080849 | Microsheath LP and LP-atSummary page 1…Panel: Cardiovascular Predicate Devices: " MicroSheath XL Support Catheter (K073289; cleared January 11, 2008) * MicroSheath LP Support Catheter (K080849; cleared July 25, 2008) Bard Peripheral Vascular, Inc. 113 =f~… | 2008 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K161986 (Bard Peripheral Vascular, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Sidekick®&and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131493: Sidekick and Usher Support Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131493
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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