510(k) · Cleared
ClearedSAYA 86 Radial Access Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on May 11, 2026 as substantially equivalent to K241388 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2025) after a 139-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- May 11, 2026
- Review
- 139 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010954 (2001). 25 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
- 2 generations backK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- 1 generation backK241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
- This deviceK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 9 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 8 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 7 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 6 generations backK082385 Chaperon Guiding CatheterMicroVention, Inc. · 2008
- 5 generations backK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
- 4 generations backK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
- 3 generations backK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
- 2 generations backK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- 1 generation backK241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
- This deviceK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −9 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −8 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −7 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −6 | K082385 | Chaperon Guiding Catheter | MicroVention, Inc. | 2008 | — |
| −5 | K131482 | Sofia Distal Access Catheter | MicroVention, Inc. | 2013 | — |
| −4 | K142014 | Sofia Distal Access Catheter | MicroVention, Inc. | 2014 | — |
| −3 | K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015 | — |
| −2 | K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| −1 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter… | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025 | — |
| 0 (this device) | K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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 |
|---|---|---|---|
| * | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Summary page 5…ct Code: QJP- Percutaneous Catheter, Neurovasculature Predicate Device: Rist™ 079 Radial Access Guide Catheter (K241388) Reference Device: FUBUKI XF Neurovascular Long Sheath (K213589) ASAHI INTECC CO., LTD.… | 2025 |
| † | K213589 | FUBUKI XF Neurovascular Long Sheath | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 25 ancestors have a recall of any class.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The SAYA 86 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254178: SAYA 86 Radial Access Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254178
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026