510(k) · Cleared
ClearedScoutpro CS Lead Introducer 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 May 7, 2008 as substantially equivalent to K060655 (Biotronik, Inc., 2006) and 3 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- May 7, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K893658 (1989). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 7 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 6 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 5 generations backK020821 Scout (Sinus Cornarius Utility Tool), Model 335 117Biotronik, Inc. · 2002
- 4 generations backK033320 Scout ProBiotronik, Inc. · 2003
- 3 generations backK060807 Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006
- 2 generations backK071665 Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007
- 1 generation backK072329 Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008
- This deviceK080988 Scoutpro CS Lead Introducer SystemBiotronik, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −7 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −6 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −5 | K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117 | Biotronik, Inc. | 2002 | — |
| −4 | K033320 | Scout Pro | Biotronik, Inc. | 2003 | — |
| −3 | K060807 | Scoutpro 7F Coronary Sinus Lead Delivery System | Biotronik, Inc. | 2006 | — |
| −2 | K071665 | Scoutpro Slitter Tool Advanced, Model 356 552 | Biotronik, Inc. | 2007 | — |
| −1 | K072329 | Scoutpro 8F, 7F and Slitter Tool Advanced | Biotronik, Inc. | 2008 | — |
| 0 (this device) | 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 |
| 2006 | 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? (4)
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 |
|---|---|---|---|
| * | K060655 | Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter…Summary page 1…as probing the coronary sinus. The following ScoutPro accessories are subject to this Special 51 0(k): The followingi ScoutPro 8F accessories were cleared under 510(k) #K060655 on April 4. 2006: The basic set ScoutPro 8F contains the following components: * 1 hemostatic valve *2 guiding cathet… | 2006 |
| * | K060807 | Scoutpro 7F Coronary Sinus Lead Delivery SystemSummary page 2…components: * 1 guiding catheter "Amplatz 6.0" · 1 dilator for the guiding catheter The following ScoutPro 7F accessories were cleared under 510(k) #K060807'on April 24, 2007: The basic set ScoutPro 7F contains the following components: * 1 hemostatic valve * 2… | 2006 |
| * | K071665 | Scoutpro Slitter Tool Advanced, Model 356 552Summary page 2…1 dilator for the guiding catheter · ScoutPro Hemostatic Valve · ScoutPro Slitter Tool The following ScoutPro accessory was cleared under 510(k) #K071665 on July 18, 2007: * ScoutPro Slitter Tool Advanced The following ScoutPro accessories were cleared under 510(k) #K072329 on Ma… | 2007 |
| * | K072329 | Scoutpro 8F, 7F and Slitter Tool AdvancedSummary page 2…ScoutPro accessory was cleared under 510(k) #K071665 on July 18, 2007: * ScoutPro Slitter Tool Advanced The following ScoutPro accessories were cleared under 510(k) #K072329 on March 25, 2008: * ScoutPro 7F Sheath "Extended Hook" contains the following components: o 1 gu… | 2008 |
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 19 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K060655.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CS Lead Introducer System facilitates lead implantation in the left of the heart via the coronary sinus.
The ScoutPro accessories are used in conjunction with the ScoutPro 8F CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080988: Scoutpro CS Lead Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080988
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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