510(k) · Cleared
ClearedPowerasset Radiofrequency Guidwire, Model Various
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DQX Wire, Guide, Catheter
Cleared on Aug 12, 2008 as substantially equivalent to K051670 (Baylis Medical Co., Inc., 2006) and 2 other predicates after a 159-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Aug 12, 2008
- Review
- 159 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K890505 (1989). 45 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 4 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 2 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 1 generation backK051670 RF Tunneler WireBaylis Medical Co., Inc. · 2006
- This deviceK080637 Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −4 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −2 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −1 | K051670 | RF Tunneler Wire | Baylis Medical Co., Inc. | 2006 | — |
| 0 (this device) | K080637 | Powerasset Radiofrequency Guidwire, Model Various | Stereotaxis, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 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.
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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K051670 | RF Tunneler WireSummary page 1…er Wire Guide * The marketed device(s) to which substantial equivalence is claimed: - Baylis Medical's RF Tunneler Wire - 510(k), K051670 - Cronus Guidewire -510(k), K042854 - Assert Guidewire - 510(k), K043457 Device… | 2006 |
| * | K042854 | Stereotaxis Endovascular Guide WireSummary page 1…which substantial equivalence is claimed: - Baylis Medical's RF Tunneler Wire - 510(k), K051670 - Cronus Guidewire -510(k), K042854 - Assert Guidewire - 510(k), K043457 Device The PARG is a sterile, single use, magnetically st… | 2005 |
| * | K043457 | Modification to Endovascular Guide WireSummary page 1…- Baylis Medical's RF Tunneler Wire - 510(k), K051670 - Cronus Guidewire -510(k), K042854 - Assert Guidewire - 510(k), K043457 Device The PARG is a sterile, single use, magnetically steerable endovascular description guidewire intended to… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K051670.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 PowerAssertTM Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080637: Powerasset Radiofrequency Guidwire, Model Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080637
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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