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 Sep 28, 2020 as substantially equivalent to K150366 (MicroVention, Inc., 2015) and 1 other predicate after a 98-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 28, 2020
- Review
- 98 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K010954 (2001). 19 ancestors in all, the oldest K925813 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 6 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 5 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 4 generations backK082385 Chaperon Guiding CatheterMicroVention, Inc. · 2008
- 3 generations backK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
- 2 generations backK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
- 1 generation backK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
- This deviceK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −6 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −5 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −4 | K082385 | Chaperon Guiding Catheter | MicroVention, Inc. | 2008 | — |
| −3 | K131482 | Sofia Distal Access Catheter | MicroVention, Inc. | 2013 | — |
| −2 | K142014 | Sofia Distal Access Catheter | MicroVention, Inc. | 2014 | — |
| −1 | K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K150366 | SOFIA 6F CatheterSummary page 4…Neurovascular Product Code: QJP Secondary Product Code: DQO Predicate Devices: SOFIA 6F Plus/Distal Access Catheter (K150366) RIST Radial Access Catheter (K200417)… | 2015 |
| * | K200417 | RIST Radial Access CatheterSummary page 4…ry Product Code: DQO Predicate Devices: SOFIA 6F Plus/Distal Access Catheter (K150366) RIST Radial Access Catheter (K200417) 1 A) Device Descrip… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist… | 2025 | 1 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 19 ancestors have a recall of any class.
- Of its descendants, K241388 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K150366.
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.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201682: 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/K201682
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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