510(k) · Cleared
ClearedScoutpro 7F Coronary Sinus Lead Delivery 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 24, 2006 as substantially equivalent to K033320 (Biotronik, Inc., 2003) after a 31-day review. Its family tree reaches back 5 generations to 1989. 5 later devices descend from it.
- Decided
- Apr 24, 2006
- Review
- 31 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K893658 (1989). 10 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 2 generations backK020821 Scout (Sinus Cornarius Utility Tool), Model 335 117Biotronik, Inc. · 2002
- 1 generation backK033320 Scout ProBiotronik, Inc. · 2003
- This deviceK060807 Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK071665 Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK072329 Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK101282 Scoutpro Hemostatic ValveBiotronik, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK093303 Scoutpro 7F Long CathetersBiotronik, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK080988 Scoutpro CS Lead Introducer SystemBiotronik, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K071665Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007 · cites it directly3descendants
- K072329Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008 · cites it directly2descendants
- K101282Scoutpro Hemostatic ValveBiotronik, Inc. · 2010 · cites it directly0descendants
- K093303Scoutpro 7F Long CathetersBiotronik, Inc. · 2009 · cites it directly0descendants
- K080988Scoutpro CS Lead Introducer SystemBiotronik, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −4 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −3 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −2 | K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117 | Biotronik, Inc. | 2002 | — |
| −1 | K033320 | Scout Pro | Biotronik, Inc. | 2003 | — |
| 0 (this device) | K060807 | Scoutpro 7F Coronary Sinus Lead Delivery System | Biotronik, Inc. | 2006 | — |
| +1 | K071665 | Scoutpro Slitter Tool Advanced, Model 356 552 | Biotronik, Inc. | 2007 | — |
| +1 | K072329 | Scoutpro 8F, 7F and Slitter Tool Advanced | Biotronik, Inc. | 2008 | — |
| +1 | K101282 | Scoutpro Hemostatic Valve | Biotronik, Inc. | 2010 | — |
| +1 | K093303 | Scoutpro 7F Long Catheters | Biotronik, Inc. | 2009 | — |
| +1 | K080988 | Scoutpro CS Lead Introducer System | Biotronik, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K033320 | Scout ProSummary page 1…ss to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's current legally marketed predicate device SccutPro (K033320, 11-19- 2003). The following ScoutPro 7F accessories are subject to this Special 510 (k) The basic set ScoutPro 7F contains the f… | 2003 |
What descends from it? (5)
5 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 17 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K071665 (Biotronik, Inc., 2007) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K033320.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060807: Scoutpro 7F Coronary Sinus Lead Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060807
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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