510(k) · Cleared
ClearedBridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001
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 Oct 8, 2008 as substantially equivalent to K970376 (Lake Region Mfg., Inc., 1997) and 2 other predicates after a 163-day review. Its family tree reaches back 6 generations to 1989. 13 later devices descend from it.
- Decided
- Oct 8, 2008
- Review
- 163 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K890505 (1989). 11 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 1 generation backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- This deviceK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
- Descendant · cites it directly · 12 of its ownK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
- Descendant · cites it directly · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- Descendant · 3 generations on · 1 of its ownK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- Descendant · 2 generations on · 1 of its ownK152401 Stingray LP CatheterBoston Scientific Corporation · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009 · cites it directly12descendants
- K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · cites it directly11descendants
- K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012 · 2 generations on5descendants
- K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020 · 3 generations on1descendant
- K152401Stingray LP CatheterBoston Scientific Corporation · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −1 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| 0 (this device) | K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire… | Bridgepoint Medical | 2008 | — |
| +1 | 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 |
| +2 | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
| +3 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | — |
| +2 | K152401 | Stingray LP Catheter | Boston Scientific Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K970376 | Ptca GuidewireSummary page 1…Medical Entera Guidewire is substantially equivalent in intended use, method of operation and technical aspects to a combination of the following predicate devices: K970376 - Lake Region PTCA guidewire/Triumph K073082 - Cordis/Brivant, Ltd. Regatta Steerable Guidewire K041531 - Asahi PTCA Guidewir… | 1997 |
| * | K073082 | CPS Courier GuidewireSummary page 1…valent in intended use, method of operation and technical aspects to a combination of the following predicate devices: K970376 - Lake Region PTCA guidewire/Triumph K073082 - Cordis/Brivant, Ltd. Regatta Steerable Guidewire K041531 - Asahi PTCA Guidewire Confianza Pro BridgePoint Medical 5 10(… | 2008 |
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 1…spects to a combination of the following predicate devices: K970376 - Lake Region PTCA guidewire/Triumph K073082 - Cordis/Brivant, Ltd. Regatta Steerable Guidewire K041531 - Asahi PTCA Guidewire Confianza Pro BridgePoint Medical 5 10(k) Submission 800-0003-01 April 26, 2008… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K083727 (Bridgepoint Medical, 2009) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K970376.
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 BridgePoint Medical Entera guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The Entera guidewires are not to be used in cerebral blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081187 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081187: Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081187
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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