510(k) · Cleared
ClearedSelectra CS Lead Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Apr 20, 2011 as substantially equivalent to K101776 (Biotronik, Inc., 2010) after a 62-day review. Its family tree reaches back 1 generation to 2010. 8 later devices descend from it.
- Decided
- Apr 20, 2011
- Review
- 62 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101776 (2010). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK101776 Scoutpro AcsBiotronik, Inc. · 2010
- This deviceK110461 Selectra CS Lead Introducer SystemBiotronik, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK123324 Selectra 7F CathetersBiotronik, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK111154 Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra…Biotronik, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK151409 Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK183265 Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK192996 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123324Selectra 7F CathetersBiotronik, Inc. · 2013 · cites it directly6descendants
- K111154Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75Biotronik, Inc. · 2011 · cites it directly6descendants
- K151409Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015 · 2 generations on5descendants
- K183265Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018 · 2 generations on4descendants
- K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101776 | Scoutpro Acs | Biotronik, Inc. | 2010 | — |
| 0 (this device) | K110461 | Selectra CS Lead Introducer System | Biotronik, Inc. | 2011 | — |
| +1 | K123324 | Selectra 7F Catheters | Biotronik, Inc. | 2013 | — |
| +1 | K111154 | Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 | Biotronik, Inc. | 2011 | — |
| +2 | K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015 | — |
| +2 | K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018 | — |
| +3 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K101776 | Scoutpro AcsSummary page 1…duct characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro ACS guiding catheters in submission K<101776, cleared on July 23, 2010. Therefore, this previously cleared version will serve as the predicate device for the modified product… | 2010 |
What descends from it? (8)
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?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110461: Selectra CS Lead Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110461
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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