510(k) · Cleared

Cleared

ShapeIT (SI014135)

K241611510(k) TraditionalCleared Sep 3, 202490-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

Imds Operations B.V. · DQY Catheter, Percutaneous

Cleared on Sep 3, 2024 as substantially equivalent to K223728 (Imds Operations B.V., 2023) after a 90-day review. Its family tree reaches back 8 generations to 1994. 3 of the 13 devices in its family, counting itself, have a Class I recall.

Decided: Sep 3, 2024
Review: 90 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 8 generations to K931794 (1994). 12 ancestors in all, the oldest K904785 (1991). No later device cites it as a predicate yet. 3 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
7 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
6 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
5 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
4 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
3 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
2 generations backK182570 Venture 0.014 CatheterVascular Solutions, LLC · 2019
1 generation backK223728 Micro RxImds Operations B.V. · 2023
This deviceK241611 ShapeIT (SI014135)Imds Operations B.V. · 2024

Class I recalls in this family

K061843 Venture Wire Control Catheter, Model WCC3 generations back · 2006
K042910 Venture Wire Control Catheter, Model WCC3 generations back · 2004
K040922 Venture Wire Control Catheter4 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
−7	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
−6	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
−5	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I
−4	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
−3	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	Class I
−2	K182570	Venture 0.014 Catheter	Vascular Solutions, LLC	2019	—
−1	K223728	Micro Rx	Imds Operations B.V.	2023	—
0 (this device)	K241611	ShapeIT (SI014135)	Imds Operations B.V.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	2	0
1997	1	0

FIG. 1 — Lineage of K241611, 1994–2024Source: 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.

3 devices in this family have 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? (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
*	K223728	Micro Rx Summary page 5 …Common/ Usual Name Catheter Classification Name Catheter, percutaneous Predicate Device K223728, Micro Rx Catheter, IMDS Operations B.V. Reference Device K182570, Venture 0.014 Catheter, Vascul…	Imds Operations B.V.	2023	—
†	K182570	Venture 0.014 Catheter	Vascular Solutions, LLC	2019	—
†	K210647	SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter	Vascular Solutions, LLC	2021	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
3 of the 12 ancestors have a recall of any class; 3 have a Class I recall.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?

The ShapeIT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature.

The device is contraindicated for use in the neurovasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K241611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241611: ShapeIT (SI014135).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241611

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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