510(k) · Cleared
ClearedTeleport XT Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrbusNeich Medical (Shenzhen) Co., Ltd. · DQY Catheter, Percutaneous
Cleared on Jan 7, 2024 as substantially equivalent to K182360 (Orbusneich Medical Trading, Inc., 2018) after a 219-day review. Its family tree reaches back 10 generations to 2000. 1 later device descends from it.
- Decided
- Jan 7, 2024
- Review
- 219 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001992 (2000). 17 ancestors in all, the oldest K945904 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations between
- 3 generations backK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
- 2 generations backK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
- 1 generation backK182360 Teleport MicrocatheterOrbusneich Medical Trading, Inc. · 2018
- This deviceK231608 Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK242588 COREPASS Modular Microcatheter (FLEX); COREPASS Modular…OrbusNeich Medical (Shenzhen) Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 9 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 8 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 7 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 6 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 5 generations backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- 4 generations backK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- 3 generations backK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
- 2 generations backK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
- 1 generation backK182360 Teleport MicrocatheterOrbusneich Medical Trading, Inc. · 2018
- This deviceK231608 Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −9 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −8 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −7 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −6 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −5 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| −4 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| −3 | K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015 | — |
| −2 | K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016 | — |
| −1 | K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| 0 (this device) | K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
| +1 | K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K182360 | Teleport MicrocatheterSummary page 4…CFR 870.1250) Regulatory Class: II Product Code: DQY Predicate Device: Teleport Microcatheter (K182360, DQY, cleared Nov 09, 2018) This predicate has not been subject to a design-related… | 2018 |
| † | K182420 | ASAHI Corsair Pro XS | 2018 |
| † | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | 2019 |
| † | K171452 | MAMBA and MAMBA FLEX Microcatheters | 2017 |
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 |
|---|---|---|---|
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | 2025 | 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 24 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K242588 (OrbusNeich Medical (Shenzhen) Co., Ltd., 2025) 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. 2024, 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 Teleport XT microcatheters are indicated for:
supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
exchanging guidewires in the coronary and peripheral vasculature.
the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
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/K231608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231608: Teleport XT Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231608
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