510(k) · Cleared
ClearedCenterCross Ultra Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roxwood Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Jun 17, 2016 as substantially equivalent to K152456 (Roxwood Medical, Inc., 2016) after a 99-day review. Its family tree reaches back 11 generations to 2000. 5 of the 51 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 17, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001992 (2000). 49 ancestors in all, the oldest P860019 (1986). 1 later device descends from it, 1 citing it directly. 5 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 7 generations between
- 3 generations backK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- 2 generations backK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- 1 generation backK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- This deviceK160681 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK170403 CenterCross Ultra LV CatheterRoxwood Medical, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 10 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 9 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 8 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 7 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 6 generations backK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
- 5 generations backK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
- 4 generations backK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
- 3 generations backK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- 2 generations backK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- 1 generation backK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- This deviceK160681 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
Class I recalls in this family
- K061843 Venture Wire Control Catheter, Model WCC5 generations back · 2006
- K060327 Vascular Solutions Twin-Pass Dual Access…5 generations back · 2006
- K052257 Vascular Solutions Twin-Pass Dual Access Catheter5 generations back · 2005
- K042910 Venture Wire Control Catheter, Model WCC6 generations back · 2004
Most influential descendants
Showing 1 of 1 · See all- K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −10 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −9 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −8 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −7 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −6 | K082339 | Enabler-P Support Catheter | Endocross, Ltd. | 2008 | — |
| −5 | K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | 2009 | — |
| −4 | K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | 2009 | — |
| −3 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
| −2 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| −1 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| 0 (this device) | K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +1 | K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 2 |
| 2005 | 2 | 1 |
| 2006 | 2 | 2 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
5 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 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 |
|---|---|---|---|
| * | K152456 | CenterCross Ultra CatheterSummary page 4…Percutaneous Catheter Classification: 21 CFR§870.1250, Class II Product Code: DQY PREDICATE DEVICE(S) CenterCross Ultra Catheter (K152456) The predicate has not been subject to a design-related recall. REFERENCE DEVICE(S) Turnpike Catheter (Vascular Solutions, Inc.,… | 2016 |
| † | K142065 | Turnpike Catheter | 2014 |
| † | K151082 | MicroCross Catheter | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170403 | CenterCross Ultra LV Catheter | 2017 | 0 |
Has anything in its family been recalled? (5 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.
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 5 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 5 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K052257Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · 5 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 49 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K170403 (Roxwood Medical, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CenterCross ULTRA Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160681 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160681: CenterCross Ultra Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160681
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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