510(k) · Cleared

Cleared

Modification to Safe-Steer Guide Wire System

K021323510(k) SpecialCleared May 22, 200226-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

Intra Luminal Therapeutics, Inc. · DQX Wire, Guide, Catheter

Cleared on May 22, 2002 as substantially equivalent to K011986 (Intra Luminal Therapeutics, Inc., 2002) after a 26-day review. Its family tree reaches back 4 generations to 1989. 75 later devices descend from it.

Decided: May 22, 2002
Review: 26 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K890505 (1989). 8 ancestors in all, the oldest K881787 (1988). 75 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
3 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
2 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
1 generation backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
This deviceK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
Descendant · cites it directly · 40 of its ownK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
Descendant · 2 generations on · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
Descendant · cites it directly · 36 of its ownK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
Descendant · 2 generations on · 31 of its ownK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
Descendant · 3 generations on · 28 of its ownK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2003high 6 (2022) · low 0 (2019)2026

Most influential descendants

Showing 5 of 75 · See all

K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003 · cites it directly40descendants
K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · 2 generations on36descendants
K032031Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004 · cites it directly36descendants
K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc. · 2007 · 2 generations on31descendants
K072776The Crosser SystemFlowcardia, Inc. · 2007 · 3 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K890505	Usci Grey/Black Guide Wire	C.R. Bard, Inc.	1989	—
−3	K961271	Usci Commander Series Guide Wires	C.R. Bard, Inc.	1996	—
−2	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat…	Guidant Corp.	1999	—
−1	K011986	Safe-Steer Guide Wire System	Intra Luminal Therapeutics, Inc.	2002	—
0 (this device)	K021323	Modification to Safe-Steer Guide Wire System	Intra Luminal Therapeutics, Inc.	2002	—
+1	K031842	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	2003	—
+2	K040067	Clirpath Excimer Laser Catheter	Spectranetics Corp.	2004	—
+1	K032031	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	2004	—
+2	K062868	The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02	Flowcardia, Inc.	2007	—
+3	K072776	The Crosser System	Flowcardia, Inc.	2007	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	2	0
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	5	0
2005	5	0
2006	1	0
2007	3	0
2008	3	0
2009	3	0
2010	3	0
2011	4	0
2012	5	0
2013	1	0
2014	3	0
2015	2	0
2016	4	0
2017	5	0
2018	3	0
2020	3	0
2021	4	0
2022	6	0
2023	5	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K021323, 1989–2026Source: 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.

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? (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
*	K011986	Safe-Steer Guide Wire System	Intra Luminal Therapeutics, Inc.	2002	—

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K031842	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	2003	40
K032031	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	2004	36

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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K031842 (Intra Luminal Therapeutics, Inc., 2003) has gone furthest, with 40 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)	—

What is it indicated for?

The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

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/K021323 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021323: Modification to Safe-Steer Guide Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021323

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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