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. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on May 27, 2022 as substantially equivalent to K142321 (Penumbra, Inc., 2015) after a 262-day review. Its family tree reaches back 6 generations to 2001. 7 later devices descend from it.
- Decided
- May 27, 2022
- Review
- 262 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). 7 later devices descend from it, 4 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 deviceK212838 Benchmark Intracranial Access SystemPenumbra, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK221822 BENCHMARK BMX81 Access SystemPenumbra, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK243593 AXS Lift Intracranial Base CatheterStryker Neurovascular · 2025
- Descendant · 2 generations on · 1 of its ownK234074 Next Generation Access CatheterBalt USA, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK254223 Next Generation 088 CatheterBalt USA, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253032 AXS Lift Intracranial Base CatheterStryker Neurovascular · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221822BENCHMARK BMX81 Access SystemPenumbra, Inc. · 2022 · cites it directly2descendants
- K243593AXS Lift Intracranial Base CatheterStryker Neurovascular · 2025 · cites it directly1descendant
- K234074Next Generation Access CatheterBalt USA, LLC · 2024 · 2 generations on1descendant
- K254223Next Generation 088 CatheterBalt USA, LLC · 2026 · 3 generations on0descendants
- K253032AXS Lift Intracranial Base CatheterStryker Neurovascular · 2026 · 2 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) | K212838 | Benchmark Intracranial Access System | Penumbra, Inc. | 2022 | — |
| +1 | K221822 | BENCHMARK BMX81 Access System | Penumbra, Inc. | 2022 | — |
| +1 | K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2025 | — |
| +2 | K234074 | Next Generation Access Catheter | Balt USA, LLC | 2024 | — |
| +3 | K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026 | — |
| +2 | K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 K240971 87 NeuGlide Catheterscore 16.6 · 8 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…: Catheter, Percutaneous, Neurovasculature Regulation Number: 21 CFR 870.1250 Product Code: QJP, DQY Predicate Device Benchmark Intracranial Access System (K142321) No reference devices were used in this submission. Device Description The Benchmark Intracranial Access System is design… | 2015 |
What descends from it? (7)
4 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 21 years and passes through 2 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, K221822 (Penumbra, Inc., 2022) 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. 2022, 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 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/K212838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212838: Benchmark Intracranial Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212838
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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