510(k) · Cleared

Cleared

Guide Catheters and Accessories

K101015510(k) TraditionalCleared Sep 23, 2010164-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

Thomas Medical Products, Inc. · DQY Catheter, Percutaneous

Cleared on Sep 23, 2010 as substantially equivalent to K021455 (Guidant Corp., 2002) and 1 other predicate after a 164-day review. Its family tree reaches back 3 generations to 1995. 1 of the 8 devices in its family, counting itself, has a Class I recall.

Decided: Sep 23, 2010
Review: 164 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K953987 (1995). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
2 generations backK021284 Easytrak Guiding CatheterGuidant Corp. · 2002 · Recalled
1 generation backK021455 Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F…Guidant Corp. · 2002 · Recalled
This deviceK101015 Guide Catheters and AccessoriesThomas Medical Products, Inc. · 2010

Class I recalls in this family

K001578 Angiodynamics Soft-VU Hydrophilic Coated…2 generations back · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K953987	Acs Tourgide Guiding Catheter	Advanced Cardiovascular Systems, Inc.	1995	—
−2	K021284	Easytrak Guiding Catheter	Guidant Corp.	2002	17
−1	K021455	Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model#…	Guidant Corp.	2002	18
0 (this device)	K101015	Guide Catheters and Accessories	Thomas Medical Products, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	2	1
2006	1	0

FIG. 1 — Lineage of K101015, 1995–2010Source: 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.

1 device in this family has a Class I recall. 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

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What was it cleared against? (2)

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
*	K021455	Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777… Summary page 1 …Guide catheters and accessories C. Legally marketed device to which equivalence is claimed: Guidant Corporation Rapido0T Guiding Catheter (K021455) and Merit Medical Systems, Inc. Impress Radiology Catheter (K053171) D. Desc…	Guidant Corp.	2002	18
*	K053171	Merit Impress Diagnostic Catheter Summary page 1 …Guidant Corporation Rapido0T Guiding Catheter (K021455) and Merit Medical Systems, Inc. Impress Radiology Catheter (K053171) D. Description of the device: The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access…	Merit Medical Systems, Inc.	2006	—

Also cleared against K021455: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K001578Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
4 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
3 other devices also cite its predicate K021455.

How does its category compare?

All DQY devices

DQY 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

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?

ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik

devices into the left ventricular coronary venous system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101015 · printed Nov 3, 2026

Cite this page

510(k) Report. “K101015: Guide Catheters and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101015

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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