510(k) · Cleared
ClearedScoutpro Acs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Jul 23, 2010 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK101776 Scoutpro AcsBiotronik, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK110461 Selectra CS Lead Introducer SystemBiotronik, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK111839 Selectra Accessory KitBiotronik, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK131978 Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK123324 Selectra 7F CathetersBiotronik, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK111154 Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra…Biotronik, Inc. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K110461Selectra CS Lead Introducer SystemBiotronik, Inc. · 2011 · cites it directly8descendants
- K111839Selectra Accessory KitBiotronik, Inc. · 2011 · cites it directly7descendants
- K131978Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2013 · 2 generations on6descendants
- K123324Selectra 7F CathetersBiotronik, Inc. · 2013 · 2 generations on6descendants
- K111154Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75Biotronik, Inc. · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101776 | Scoutpro Acs | Biotronik, Inc. | 2010 | — |
| +1 | K110461 | Selectra CS Lead Introducer System | Biotronik, Inc. | 2011 | — |
| +1 | K111839 | Selectra Accessory Kit | Biotronik, Inc. | 2011 | — |
| +2 | K131978 | Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2013 | — |
| +2 | K123324 | Selectra 7F Catheters | Biotronik, Inc. | 2013 | — |
| +2 | K111154 | Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 | Biotronik, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 153 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?
- Of its descendants, K110461 (Biotronik, Inc., 2011) has gone furthest, with 8 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. 2010, 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 ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS 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 510(k) statement.
https://510kreport.com/device/K101776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101776: Scoutpro Acs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101776
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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