510(k) · Cleared
ClearedSelectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Sep 12, 2024 as substantially equivalent to K222037 (Biotronik, Inc., 2022) after a 174-day review. Its family tree reaches back 8 generations to 2010.
- Decided
- Sep 12, 2024
- Review
- 174 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K101776 (2010). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK101776 Scoutpro AcsBiotronik, Inc. · 2010
- 7 generations backK110461 Selectra CS Lead Introducer SystemBiotronik, Inc. · 2011
- 6 generations backK111154 Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra…Biotronik, Inc. · 2011
- 5 generations backK151409 Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015
- 4 generations backK183265 Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018
- 3 generations backK192996 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019
- 2 generations backK193474 Selectra 3D Outer Guiding CathetersBiotronik, Inc. · 2020
- 1 generation backK222037 Selectra Lead Implantation SystemBiotronik, Inc. · 2022
- This deviceK240787 Selectra 3D Lead Delivery System (443624-443629, 451789-451791)…Biotronik, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K101776 | Scoutpro Acs | Biotronik, Inc. | 2010 | — |
| −7 | K110461 | Selectra CS Lead Introducer System | Biotronik, Inc. | 2011 | — |
| −6 | K111154 | Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 | Biotronik, Inc. | 2011 | — |
| −5 | K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015 | — |
| −4 | K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018 | — |
| −3 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2019 | — |
| −2 | K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | 2020 | — |
| −1 | K222037 | Selectra Lead Implantation System | Biotronik, Inc. | 2022 | — |
| 0 (this device) | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra… | Biotronik, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K222037 | Selectra Lead Implantation SystemSummary page 5…II Product Code DQY III. Predicate Devices BIOTRONIK’s Selectra 3D Catheters, Selectra Accessory Kit and Selectra Slitter Tool (K222037 cleared July 19, 2022). IV. Device Description BIOTRONIK's Selectra 3D lead introducer system is a combination of guiding… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 lead delivery system, consisting of Selectra catheters in conjunction with the Selectra Accessory Kit, is used to facilitate implantation of leads in the heart chambers or in the coronary veins via the coronary sinus.
Selectra 3D catheters are also indicated to facilitate Solia S lead implantation in the left bundle branch area to achieve left bundle area pacing (LBBAP).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240787: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240787
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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