510(k) · Cleared

Cleared

Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque Devi

K921702510(k) TraditionalCleared Sep 21, 1992164-day reviewClass II21 CFR 870.1330

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

Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Sep 21, 1992 after a 164-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 30 later devices descend from it.

Decided: Sep 21, 1992
Review: 164 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

30 later devices descend from it, 1 citing it directly.

This deviceK921702 Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque DeviMerit Medical Systems, Inc. · 1992
Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
Descendant · 2 generations on · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
Descendant · 3 generations on · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
Descendant · 4 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
Descendant · 5 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003high 5 (2006) · low 0 (2012)2026

Most influential descendants

Showing 5 of 30 · See all

K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · 2 generations on17descendants
K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · 3 generations on14descendants
K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 4 generations on13descendants
K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 5 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K921702	Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque Devi	Merit Medical Systems, Inc.	1992	—
+1	K031211	Attain Prevail Steerable Catheter Set, Model 6228CTH	Medtronic Vascular	2003	—
+2	K042194	Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery	Medtronic Vascular	2004	—
+3	K053431	Attain Select II 6248DEL Delivery Catheter System	Medtronic, Ireland	2006	—
+4	K080428	Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide…	Medtronic, Inc.	2008	—
+5	K090659	Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left…	Medtronic, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	1	0
2006	5	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0
2018	2	0
2019	2	0
2020	2	0
2022	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K921702, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031211	Attain Prevail Steerable Catheter Set, Model 6228CTH	Medtronic Vascular	2003	29

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?

Of its descendants, K031211 (Medtronic Vascular, 2003) has gone furthest, with 29 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)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)	—

https://510kreport.com/device/K921702 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921702: Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque Devi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921702

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026