510(k) · Cleared
ClearedHoudini Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cruzar Medsystems, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 7, 2015 as substantially equivalent to K083833 (Endocross, Ltd., 2009) after a 150-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Dec 7, 2015
- Review
- 150 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001992 (2000). 9 ancestors in all, the oldest K972744 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 5 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 4 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 3 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 2 generations backK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
- 1 generation backK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
- This deviceK151896 Houdini CatheterCruzar Medsystems, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK213466 Houdini Cross Support CatheterCruzar Medsystems, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213466Houdini Cross Support CatheterCruzar Medsystems, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −6 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −5 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −3 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | K082339 | Enabler-P Support Catheter | Endocross, Ltd. | 2008 | — |
| −1 | K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | 2009 | — |
| 0 (this device) | K151896 | Houdini Catheter | Cruzar Medsystems, Inc. | 2015 | — |
| +1 | K213466 | Houdini Cross Support Catheter | Cruzar Medsystems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K083833 | Enabler-P Catheter, 1000 Part Number:1160Summary page 4…DEVICE Device Name: ENDOCROSS, ENABLER-P CATHETER, 1000 PART NUMBER: 1160 510(k) Applicant: ENDOCROSS, LTD 510(k): K083833 There has been no recall on the Endocross Enabler-P device. 4. DEVICE DESCRIPTION The Houdini Catheter is a single use, dual-l… | 2009 |
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 |
|---|---|---|---|
| K213466 | Houdini Cross Support Catheter | 2022 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K213466 (Cruzar Medsystems, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083833.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Cruzar Medsystems Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151896: Houdini Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151896
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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