510(k) · Cleared
ClearedBridgepoint Medical Crossboss Catheter, Model M-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridgepoint Medical · DQY Catheter, Percutaneous
Cleared on Sep 2, 2009 as substantially equivalent to K081130 (Bridgepoint Medical, 2009) after a 72-day review. Its family tree reaches back 6 generations to 2000. 13 later devices descend from it.
- Decided
- Sep 2, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001992 (2000). 10 ancestors in all, the oldest K911547 (1991). 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 5 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 4 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 3 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 2 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 1 generation backK081130 Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical · 2009
- This deviceK091841 Bridgepoint Medical Crossboss Catheter, Model M-2000Bridgepoint 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 · cites it directly · 6 of its ownK113589 Bigboss CatheterBridgepoint Medical · 2012
- 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- K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · cites it directly11descendants
- K113589Bigboss CatheterBridgepoint Medical · 2012 · cites it directly6descendants
- 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 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −5 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −4 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −3 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −2 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K081130 | Bridgepoint Medical Crossboss Percutaneous Coronary Catheter | Bridgepoint Medical | 2009 | — |
| 0 (this device) | K091841 | Bridgepoint Medical Crossboss Catheter, Model M-2000 | Bridgepoint Medical | 2009 | — |
| +1 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model… | Bridge Medical, Inc. | 2011 | 1 |
| +1 | K113589 | Bigboss Catheter | Bridgepoint Medical | 2012 | — |
| +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 |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K081130 | Bridgepoint Medical Crossboss Percutaneous Coronary CatheterSummary page 1…The BridgePoint Medical CrossBoss Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K081 130 - CrossBossTM Catheter Device Description: The CrossBoss Catheter is a single use over the wire disposable percutaneous Cathe… | 2009 |
What descends from it? (13)
See all 132 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 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K102725 (Bridge Medical, Inc., 2011) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K081130.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The BridgePoint Medical CrossBossTM Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronaty or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091841: Bridgepoint Medical Crossboss Catheter, Model M-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091841
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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