510(k) · Cleared
ClearedBenchmark Intracranial Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · DQY Catheter, Percutaneous
Cleared on Jan 26, 2015 as substantially equivalent to K082290 (Penumbra, Inc., 2008) and 1 other predicate after a 160-day review. Its family tree reaches back 5 generations to 2001. 16 later devices descend from it.
- Decided
- Jan 26, 2015
- Review
- 160 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010954 (2001). 7 ancestors in all, the oldest K010853 (2001). 16 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 3 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 2 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 1 generation backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- This deviceK142321 Benchmark Intracranial Access SystemPenumbra, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK212838 Benchmark Intracranial Access SystemPenumbra, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK200417 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK181000 SelectFlex 072 Neurovascular Access SystemQ'Apel · 2018
- Descendant · 2 generations on · 2 of its ownK221822 BENCHMARK BMX81 Access SystemPenumbra, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K212838Benchmark Intracranial Access SystemPenumbra, Inc. · 2022 · cites it directly7descendants
- K200417RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · cites it directly3descendants
- K181000SelectFlex 072 Neurovascular Access SystemQ'Apel · 2018 · cites it directly3descendants
- K221822BENCHMARK BMX81 Access SystemPenumbra, Inc. · 2022 · 2 generations on2descendants
- K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −3 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −2 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −1 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| 0 (this device) | K142321 | Benchmark Intracranial Access System | Penumbra, Inc. | 2015 | — |
| +1 | K212838 | Benchmark Intracranial Access System | Penumbra, Inc. | 2022 | — |
| +1 | K200417 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| +1 | K181000 | SelectFlex 072 Neurovascular Access System | Q'Apel | 2018 | — |
| +2 | K221822 | BENCHMARK BMX81 Access System | Penumbra, Inc. | 2022 | — |
| +2 | K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K082290 | Neuron Delivery Catheter 070Summary page 4…Name of Name of Predicate Device Clearance Date Manufacturer K082290 / 31Oct2008 Neuron Delivery Catheter 070 Penumbra, Inc. K083125 / 21Nov2008 Neuron Select Catheter… | 2008 |
| * | K083125 | Neuron Select Catheter Size 070Summary page 4…Clearance Date Manufacturer K082290 / 31Oct2008 Neuron Delivery Catheter 070 Penumbra, Inc. K083125 / 21Nov2008 Neuron Select Catheter 070 Penumbra, Inc. 7.7 Predicate Comparison… | 2008 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K212838 (Penumbra, Inc., 2022) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K082290.
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 Benchmark™ Intracranial Access System 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/K142321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142321: Benchmark Intracranial Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142321
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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