510(k) · Cleared

Cleared

S-Wire Guidewire System

K153397510(k) TraditionalCleared Aug 18, 2016268-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

Concert Medical, LLC · DQX Wire, Guide, Catheter

Cleared on Aug 18, 2016 as substantially equivalent to K151244 (Lake Region Medical, 2015) and 1 other predicate after a 268-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.

Decided: Aug 18, 2016
Review: 268 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K930622 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK930622 Amplatz GuidewiresMeadox Medicals, Div. Boston Scientific Corp. · 1993
2 generations backK130798 Pre-Formed GuidewiresLake Region Medical, Inc. · 2013
1 generation backK151244 Pre-Formed GuidewireLake Region Medical · 2015
This deviceK153397 S-Wire Guidewire SystemConcert Medical, LLC · 2016
Descendant · cites it directly · 0 of its ownK171445 Amplatz Support Wire Guide with Apex CurveCook Incorporated · 2018

Most influential descendants

Showing 1 of 1 · See all

K171445Amplatz Support Wire Guide with Apex CurveCook Incorporated · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930622	Amplatz Guidewires	Meadox Medicals, Div. Boston Scientific Corp.	1993	—
−2	K130798	Pre-Formed Guidewires	Lake Region Medical, Inc.	2013	—
−1	K151244	Pre-Formed Guidewire	Lake Region Medical	2015	—
0 (this device)	K153397	S-Wire Guidewire System	Concert Medical, LLC	2016	—
+1	K171445	Amplatz Support Wire Guide with Apex Curve	Cook Incorporated	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K153397, 1993–2018Source: 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 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? (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
*	K151244	Pre-Formed Guidewire Summary page 4 …Lake Region Pre-Formed Guidewire (Boston Scientific Safari Pre-Shaped TAVI Guidewire) Catheter Guide Wire DQX 21 CFR 870.1330 — Catheter Guide Wire Class 11 K130798, K151244 The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambe…	Lake Region Medical	2015	—
*	K130798	Pre-Formed Guidewires Summary page 4 …lass 11 Lake Region Pre-Formed Guidewire (Boston Scientific Safari Pre-Shaped TAVI Guidewire) Catheter Guide Wire DQX 21 CFR 870.1330 — Catheter Guide Wire Class 11 K130798, K151244 The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within t…	Lake Region Medical, Inc.	2013	—

Also cleared against K151244: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K171445	Amplatz Support Wire Guide with Apex Curve	Cook Incorporated	2018	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?

The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K171445 (Cook Incorporated, 2018) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K151244.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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)	—

What is it indicated for?

The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.

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/K153397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K153397: S-Wire Guidewire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153397

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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