510(k) · Cleared
ClearedUsci Commander Series Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQX Wire, Guide, Catheter
Cleared on Jun 27, 1996 as substantially equivalent to K890505 (C.R. Bard, Inc., 1989) after an 86-day review. Its family tree reaches back 1 generation to 1989. 3 of the 193 devices in its family, counting itself, have a Class I recall. 191 later devices descend from it.
- Decided
- Jun 27, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890505 (1989). 191 later devices descend from it, 2 citing it directly. 3 of the 193 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- This deviceK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- Descendant · cites it directly · 189 of its ownK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- Descendant · 2 generations on · 104 of its ownK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- Descendant · 3 generations on · 92 of its ownK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- Descendant · 3 generations on · 79 of its ownK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- Descendant · 2 generations on · 76 of its ownK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
Showing 5 of 191 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 191 · See all- K990639Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…Guidant Corp. · 1999 · cites it directly189descendants
- K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc. · 2002 · 2 generations on104descendants
- K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003 · 3 generations on92descendants
- K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004 · 3 generations on79descendants
- K011986Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002 · 2 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| 0 (this device) | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| +1 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| +2 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| +3 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| +3 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +2 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 1 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 1 |
| 2022 | 14 | 0 |
| 2023 | 12 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 1 |
| 2026 | 4 | 0 |
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.
3 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
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 | Decided |
|---|---|---|---|
| * | K890505 | Usci Grey/Black Guide WireSummary page 2…atheter Guide Wire for PTCA Catheter L 4 Device Classification: 21 CFR 870.4290 [BARID & USCI® Phantom™ Guide Wire (concurrence received June 20, 1989, K890505) USCI® LumiSilk Guide Wire (concurrence received March 1, 1993, K925074/A) USCI® Standard Guide Wire (approval received October 7… | 1989 |
| † | K925074 | Usci Lumisilk Guide Wire with Pro/Pel Coating | 1993 |
| † | P790017 | Usci Dilatation Catheter | 1980 |
| † | K890515 | Peripheral Atherectomy System | 1989 |
What descends from it? (191)
See all 1912 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 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, K990639 (Guidant Corp., 1999) has gone furthest, with 189 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 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 Commander Series Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The Commander Series guide wires are not intended for use in the cerebral vasculature, Commander steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
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/K961271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961271: Usci Commander Series Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961271
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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