510(k) · Cleared
ClearedScout (Sinus Cornarius Utility Tool), Model 335 117
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQX Wire, Guide, Catheter
Cleared on Jun 3, 2002 as substantially equivalent to K012130 (Medtronic Vascular, 2001) after an 82-day review. Its family tree reaches back 3 generations to 1989. 8 later devices descend from it.
- Decided
- Jun 3, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K893658 (1989). 8 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 2 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 1 generation backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- This deviceK020821 Scout (Sinus Cornarius Utility Tool), Model 335 117Biotronik, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK033320 Scout ProBiotronik, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK060807 Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK071665 Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK060655 Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook…Biotronik, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK072329 Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K033320Scout ProBiotronik, Inc. · 2003 · cites it directly7descendants
- K060807Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006 · 2 generations on5descendants
- K071665Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007 · 3 generations on3descendants
- K060655Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter…Biotronik, Inc. · 2006 · 2 generations on3descendants
- K072329Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −2 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −1 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| 0 (this device) | K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117 | Biotronik, Inc. | 2002 | — |
| +1 | K033320 | Scout Pro | Biotronik, Inc. | 2003 | — |
| +2 | K060807 | Scoutpro 7F Coronary Sinus Lead Delivery System | Biotronik, Inc. | 2006 | — |
| +3 | K071665 | Scoutpro Slitter Tool Advanced, Model 356 552 | Biotronik, Inc. | 2007 | — |
| +2 | K060655 | Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding… | Biotronik, Inc. | 2006 | — |
| +3 | K072329 | Scoutpro 8F, 7F and Slitter Tool Advanced | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K012130 | Attain LDS 6216 Left-Heart Delivery SystemSummary page 1…functionally equivalent t o market- released delivery systems. In specific, the materials used and'design are similar to Medtronic's LDS 6216 Left-Heart Delivery System IK012130, cleared 08-28-011. Indication for Use: The intended use of the SCOUT Accessories for Implantation in the Coronary Sinus is for… | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033320 | Scout Pro | 2003 | 7 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K033320 (Biotronik, Inc., 2003) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K012130.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed 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/K020821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020821: Scout (Sinus Cornarius Utility Tool), Model 335 117.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020821
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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