510(k) · Cleared
Recalled · Class II · 2018Stingray Guidewires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridgepoint Medical · DQX Wire, Guide, Catheter
Cleared on Nov 8, 2012 as substantially equivalent to K081187 (Bridgepoint Medical, 2008) and 2 other predicates after a 57-day review. Its family tree reaches back 9 generations to 1989. 3 of the 55 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Nov 8, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K890505 (1989). 54 ancestors in all, the oldest K884647 (1989). No later device cites it as a predicate yet. 3 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations between
- 3 generations backK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
- 2 generations backK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
- 1 generation backK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
- This deviceK122795 Stingray GuidewiresBridgepoint Medical · 2012
Show all 9 generations
- Root · 9 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 7 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 6 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 5 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 4 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 3 generations backK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
- 2 generations backK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
- 1 generation backK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
- This deviceK122795 Stingray GuidewiresBridgepoint Medical · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −8 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −7 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −6 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −5 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −4 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −3 | K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire… | Bridgepoint Medical | 2008 | — |
| −2 | K083727 | Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012 | Bridgepoint Medical | 2009 | — |
| −1 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model… | Bridge Medical, Inc. | 2011 | 1 |
| 0 (this device) | K122795 | Stingray Guidewires | Bridgepoint Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 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? (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 |
|---|---|---|---|
| * | K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Summary page 1…fied BridgePoint Medical StingrayTM Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K081 187 and K083727 - StingrayTM Guidewires K102725 - BridgePoint Medical System consisting of the CrossBossTM Catheter, StingrayTM Cathe… | 2008 |
| * | K083727 | Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Summary page 1…int Medical StingrayTM Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K081 187 and K083727 - StingrayTM Guidewires K102725 - BridgePoint Medical System consisting of the CrossBossTM Catheter, StingrayTM Catheter and Stin… | 2009 |
| * | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Summary page 1…s are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K081 187 and K083727 - StingrayTM Guidewires K102725 - BridgePoint Medical System consisting of the CrossBossTM Catheter, StingrayTM Catheter and StingrayTM Guidewire… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2018 | Class II | Z-0852-2019 | Labeling mix-ups | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. |
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.
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K081187.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 BridgePoint Medical Stingray Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray Guidewires are not to be used in the cerebral blood vessels.
When used as part of the BridgePoint Medical System (consisting of the CrossBoss Catheter, Stingray Catheter, and Stingray Guidewire), the Stingray Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122795: Stingray Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122795
Report an extraction error
Are you the manufacturer?
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