510(k) · Cleared

Cleared

Amplatz Guidewires

K930622510(k) TraditionalCleared Apr 29, 199380-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

Meadox Medicals, Div. Boston Scientific Corp. · DQX Wire, Guide, Catheter

Cleared on Apr 29, 1993 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Apr 29, 1993
Review: 80 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK930622 Amplatz GuidewiresMeadox Medicals, Div. Boston Scientific Corp. · 1993
Descendant · cites it directly · 11 of its ownK130798 Pre-Formed GuidewiresLake Region Medical, Inc. · 2013
Descendant · 2 generations on · 10 of its ownK151244 Pre-Formed GuidewireLake Region Medical · 2015
Descendant · 3 generations on · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
Descendant · 4 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
Descendant · 2 generations on · 1 of its ownK153397 S-Wire Guidewire SystemConcert Medical, LLC · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 13 · See all

K130798Pre-Formed GuidewiresLake Region Medical, Inc. · 2013 · cites it directly11descendants
K151244Pre-Formed GuidewireLake Region Medical · 2015 · 2 generations on10descendants
K213854SavvyWireOpsens, Inc. · 2022 · 3 generations on4descendants
K241418OptoMonitor 3Opsens, Inc. · 2025 · 4 generations on1descendant
K153397S-Wire Guidewire SystemConcert Medical, LLC · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930622	Amplatz Guidewires	Meadox Medicals, Div. Boston Scientific Corp.	1993	—
+1	K130798	Pre-Formed Guidewires	Lake Region Medical, Inc.	2013	—
+2	K151244	Pre-Formed Guidewire	Lake Region Medical	2015	—
+3	K213854	SavvyWire	Opsens, Inc.	2022	—
+4	K241418	OptoMonitor 3	Opsens, Inc.	2025	—
+2	K153397	S-Wire Guidewire System	Concert Medical, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	2	0
2016	1	0
2018	1	0
2021	1	0
2022	2	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K930622, 1993–2026Source: 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K130798	Pre-Formed Guidewires	Lake Region Medical, Inc.	2013	11
K143613	PaxWire Occlusion Balloon System	Accessclosure, Inc.	2015	0

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, K130798 (Lake Region Medical, Inc., 2013) has gone furthest, with 11 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/K930622 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930622: Amplatz Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930622

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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