510(k) · Cleared

Cleared

Scout Pro

K033320510(k) SpecialCleared Nov 19, 200335-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biotronik, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 19, 2003 as substantially equivalent to K020821 (Biotronik, Inc., 2002) after a 35-day review. Its family tree reaches back 4 generations to 1989. 7 later devices descend from it.

Decided: Nov 19, 2003
Review: 35 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K893658 (1989). 9 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
3 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
2 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
1 generation backK020821 Scout (Sinus Cornarius Utility Tool), Model 335 117Biotronik, Inc. · 2002
This deviceK033320 Scout ProBiotronik, Inc. · 2003
Descendant · cites it directly · 5 of its ownK060807 Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006
Descendant · 2 generations on · 3 of its ownK071665 Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007
Descendant · cites it directly · 3 of its ownK060655 Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook…Biotronik, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK072329 Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008
Descendant · 2 generations on · 0 of its ownK101282 Scoutpro Hemostatic ValveBiotronik, Inc. · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006high 2 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all

K060807Scoutpro 7F Coronary Sinus Lead Delivery SystemBiotronik, Inc. · 2006 · cites it directly5descendants
K071665Scoutpro Slitter Tool Advanced, Model 356 552Biotronik, Inc. · 2007 · 2 generations on3descendants
K060655Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter…Biotronik, Inc. · 2006 · cites it directly3descendants
K072329Scoutpro 8F, 7F and Slitter Tool AdvancedBiotronik, Inc. · 2008 · 2 generations on2descendants
K101282Scoutpro Hemostatic ValveBiotronik, Inc. · 2010 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K893658	Percutaneous Introducer	Medamicus, Inc.	1989	—
−3	K965167	Percutaneous Venous Introducer 10264	Medamicus, Inc.	1997	—
−2	K012130	Attain LDS 6216 Left-Heart Delivery System	Medtronic Vascular	2001	—
−1	K020821	Scout (Sinus Cornarius Utility Tool), Model 335 117	Biotronik, Inc.	2002	—
0 (this device)	K033320	Scout Pro	Biotronik, Inc.	2003	—
+1	K060807	Scoutpro 7F Coronary Sinus Lead Delivery System	Biotronik, Inc.	2006	—
+2	K071665	Scoutpro Slitter Tool Advanced, Model 356 552	Biotronik, Inc.	2007	—
+1	K060655	Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding…	Biotronik, Inc.	2006	—
+2	K072329	Scoutpro 8F, 7F and Slitter Tool Advanced	Biotronik, Inc.	2008	—
+2	K101282	Scoutpro Hemostatic Valve	Biotronik, Inc.	2010	—

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
2006	2	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K033320, 1989–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K020821	Scout (Sinus Cornarius Utility Tool), Model 335 117 Summary page 1 …the coronary sinus venous system as well as probing of the coronary sinus. The ScoutPro has been expanded and modified from BIOTRONIKs currently legally marketed SCOUT (K020821, 06-03-02). The following ScoutPro accessories are the subjects of this 510(k): ScoutPro 8F that contains the following component…	Biotronik, Inc.	2002	—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060807	Scoutpro 7F Coronary Sinus Lead Delivery System	Biotronik, Inc.	2006	5
K060655	Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter…	Biotronik, Inc.	2006	3

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 14 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
2 of the 9 ancestors have a recall of any class.
Of its descendants, K060807 (Biotronik, Inc., 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)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 is for introducing leads into the vessels of the left heart via the coronary sinus.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K033320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033320: Scout Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033320

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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