510(k) · Cleared

Cleared

Radius Cougar Wire

K011287510(k) SpecialCleared May 25, 200128-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

Radius Medical Technologies, Inc. · DQX Wire, Guide, Catheter

Cleared on May 25, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 51 devices in its family, counting itself, have a Class I recall. 50 later devices descend from it.

Decided: May 25, 2001
Review: 28 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

50 later devices descend from it, 4 citing it directly. 6 of the 51 devices in this family, counting this one, have a Class I recall.

This deviceK011287 Radius Cougar WireRadius Medical Technologies, Inc. · 2001
Descendant · cites it directly · 47 of its ownK032129 Radius 018 Cougar WireRadius Medical Technologies, Inc. · 2003
Descendant · cites it directly · 36 of its ownK061171 Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc. · 2006
Descendant · 2 generations on · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
Descendant · 3 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
Descendant · 4 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2003high 8 (2012) · low 0 (2004)2026

Class I recalls in this family

K032899 Radius Cougar Wirecites it directly · 2003
K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024

Most influential descendants

Showing 5 of 50 · See all

K032129Radius 018 Cougar WireRadius Medical Technologies, Inc. · 2003 · cites it directly47descendants
K061171Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc. · 2006 · cites it directly36descendants
K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · 2 generations on35descendants
K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 3 generations on30descendants
K110256The IC-Pro SystemPaieon, Inc. · 2011 · 4 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011287	Radius Cougar Wire	Radius Medical Technologies, Inc.	2001	—
+1	K032129	Radius 018 Cougar Wire	Radius Medical Technologies, Inc.	2003	—
+1	K061171	Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX	Biosphere Medical, Inc.	2006	—
+2	K062192	Ostial Pro Stent Positioning System	Ostial Solutions, LLC	2007	—
+3	K083745	The IC-Pro System, Model Version 3.2	Paieon, Inc.	2009	—
+4	K110256	The IC-Pro System	Paieon, Inc.	2011	—

Descendants by year cleared

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

FIG. 1 — Lineage of K011287, 2001–2026Source: 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.

6 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?

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

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K032129	Radius 018 Cougar Wire	Radius Medical Technologies, Inc.	2003	47
K061171	Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX	Biosphere Medical, Inc.	2006	36
K060551	Brivant Guidewire	Brivant Limited	2006	9
K032899	Radius Cougar Wire Class I	Radius Medical Technologies, Inc.	2003	1

Has anything in its family been recalled? (6 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.

K032899Radius Cougar WireRadius Medical Technologies, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 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 · 7 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 · 7 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 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K032129 (Radius Medical Technologies, Inc., 2003) has gone furthest, with 47 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/K011287 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011287: Radius Cougar Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011287

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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