510(k) · Cleared
ClearedSelectra Accessory Kit, Selectra Slitter Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 23, 2013 as substantially equivalent to K111839 (Biotronik, Inc., 2011) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 2010. 6 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K101776 (2010). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK101776 Scoutpro AcsBiotronik, Inc. · 2010
- 1 generation backK111839 Selectra Accessory KitBiotronik, Inc. · 2011
- This deviceK131978 Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK151409 Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK183265 Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK192996 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK193474 Selectra 3D Outer Guiding CathetersBiotronik, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK222037 Selectra Lead Implantation SystemBiotronik, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151409Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015 · cites it directly5descendants
- K183265Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018 · cites it directly4descendants
- K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019 · 2 generations on3descendants
- K193474Selectra 3D Outer Guiding CathetersBiotronik, Inc. · 2020 · 3 generations on2descendants
- K222037Selectra Lead Implantation SystemBiotronik, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101776 | Scoutpro Acs | Biotronik, Inc. | 2010 | — |
| −1 | K111839 | Selectra Accessory Kit | Biotronik, Inc. | 2011 | — |
| 0 (this device) | K131978 | Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2013 | — |
| +1 | K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015 | — |
| +1 | K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018 | — |
| +2 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2019 | — |
| +3 | K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | 2020 | — |
| +3 | K222037 | Selectra Lead Implantation System | Biotronik, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K111839 | Selectra Accessory KitSummary page 1…ion: Class 11 (21 CFR 870.1330) Product Code: DQX, OQY Predicate Devices: * Selectra Accessory Kit (K1 11839, dated September 26, 2011) * Selectra Slitter Tool (K1 12482, dated September 26, 2011) Indications for Use: The Selectra Ac… | 2011 |
| * | K112482 | Selectra Slitter ToolSummary page 1…Product Code: DQX, OQY Predicate Devices: * Selectra Accessory Kit (K1 11839, dated September 26, 2011) * Selectra Slitter Tool (K1 12482, dated September 26, 2011) Indications for Use: The Selectra Accessory Kit/Selectra Slitter Tool is used in conjunction with the… | 2011 |
What descends from it? (6)
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 3 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151409 (Biotronik, Inc., 2015) has gone furthest, with 5 descendants 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 Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system 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/K131978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131978: Selectra Accessory Kit, Selectra Slitter Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131978
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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