510(k) · Cleared
ClearedRIST Radial Access Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rist Neurovascular, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on May 2, 2020 as substantially equivalent to K142321 (Penumbra, Inc., 2015) after a 72-day review. Its family tree reaches back 6 generations to 2001. 3 later devices descend from it.
- Decided
- May 2, 2020
- Review
- 72 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010954 (2001). 8 ancestors in all, the oldest K010853 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 4 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 3 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 2 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 1 generation backK142321 Benchmark Intracranial Access SystemPenumbra, Inc. · 2015
- This deviceK200417 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
- Descendant · 3 generations on · 0 of its ownK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · cites it directly2descendants
- K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025 · 2 generations on1descendant
- K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −4 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −3 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −2 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −1 | K142321 | Benchmark Intracranial Access System | Penumbra, Inc. | 2015 | — |
| 0 (this device) | K200417 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| +1 | K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| +2 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter… | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K142321 | Benchmark Intracranial Access SystemSummary page 4…QJP, DQY Predicate Device: Penumbra, Inc. Benchmark Intracranial Access System (5F Select Catheter), #K142321 Reference Predicate: RIST Cath Radial Access Long Sheath, #K191551… | 2015 |
| † | K191551 | RIST Cath Radial Access Long Sheath | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201682 | RIST Radial Access Catheter | 2020 | 2 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K201682 (Rist Neurovascular, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K142321.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary,
and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200417: RIST Radial Access Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200417
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