510(k) · Cleared

Recalled · 2009

Streerable Ptca Guidewire

K011968510(k) SpecialCleared Jul 25, 200130-day reviewClass II21 CFR 870.1330Recalls 2

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

Lake Region Mfg., Inc. · DQX Wire, Guide, Catheter

Cleared on Jul 25, 2001 as substantially equivalent to K970376 (Lake Region Mfg., Inc., 1997) after a 30-day review. Its family tree reaches back 1 generation to 1997. 5 of the 72 devices in its family, counting itself, have a Class I recall. 70 later devices descend from it. It has been recalled 2 times.

Decided: Jul 25, 2001
Review: 30 days
Class: Class II
Product code: DQX
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K970376 (1997). 70 later devices descend from it, 4 citing it directly. 5 of the 72 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
This deviceK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001
Descendant · cites it directly · 49 of its ownK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
Descendant · 2 generations on · 36 of its ownK042338 Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004
Descendant · 3 generations on · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
Descendant · 4 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
Descendant · 5 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2003high 8 (2012) · low 0 (2020)2026

Class I recalls in this family

K190106 Intra-Operative Positioning System; Simple Curve…7 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
K230309 Intra-Operative Positioning System (IOPS®)…8 generations on · 2023

Most influential descendants

Showing 5 of 70 · See all

K022813Steerable GuidewireLake Region Mfg., Inc. · 2003 · cites it directly49descendants
K042338Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004 · 2 generations on36descendants
K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · 3 generations on35descendants
K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 4 generations on30descendants
K110256The IC-Pro SystemPaieon, Inc. · 2011 · 5 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970376	Ptca Guidewire	Lake Region Mfg., Inc.	1997	—
0 (this device)	K011968	Streerable Ptca Guidewire	Lake Region Mfg., Inc.	2001	—
+1	K022813	Steerable Guidewire	Lake Region Mfg., Inc.	2003	—
+2	K042338	Coronary Peripheral and Renal Steerable Guidewire	Lake Region Mfg., Inc.	2004	—
+3	K062192	Ostial Pro Stent Positioning System	Ostial Solutions, LLC	2007	—
+4	K083745	The IC-Pro System, Model Version 3.2	Paieon, Inc.	2009	—
+5	K110256	The IC-Pro System	Paieon, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	5	0
2005	2	0
2006	3	0
2007	2	0
2008	3	0
2009	4	0
2010	4	0
2011	2	0
2012	8	0
2013	1	0
2014	4	0
2015	3	0
2016	3	0
2017	2	0
2018	3	0
2019	3	1
2021	1	0
2023	3	1
2024	3	2
2025	4	1
2026	4	0

FIG. 1 — Lineage of K011968, 1997–2026Source: 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.

5 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 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? (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
*	K970376	Ptca Guidewire Summary page 2 …Floppy to Support Engineering Specifications The design specifications are the same for the proposed device as they are for the LRM predicate device [reference 510(k) K970376]. The finished devices must meet the same basic design criteria. 2.5 Substantial Equivalence Data 25.1 Background Information…	Lake Region Mfg., Inc.	1997	—

Also cleared against K970376: 6 other devices →

What descends from it? (70)

See all 70

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

Number	Device	Applicant	Decided	Descendants
K022813	Steerable Guidewire	Lake Region Mfg., Inc.	2003	49
K030617	PT2 Guide Wire and Addwire Extension Wire	Boston Scientific Scimed, Inc.	2003	11
K041624	Ptca Steerable Hydrophilic Guidewire	Lake Region Mfg., Inc.	2004	4
K040592	Cordis Steer-IT Deflecting Tip Guidewire	Cordis Corp.	2004	2

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2009	Not classified	Z-1486-2009	Process control	Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since…
May 12, 2009	Not classified	Z-1487-2009	Process control	Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since…

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.

K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K022813 (Lake Region Mfg., Inc., 2003) has gone furthest, with 49 descendants of its own.
6 other devices also cite its predicate K970376.

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)	—

What is it indicated for?

For use in angiographic procedures to introduce and position catheters and

interventional devices within the coronary and peripheral vasculature

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/K011968 · printed Nov 3, 2026

Cite this page

510(k) Report. “K011968: Streerable Ptca Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K011968

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026