510(k) · Cleared
ClearedNeurovascular Access System Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q'Apel Medical, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Nov 20, 2024 as substantially equivalent to K212838 (Penumbra, Inc., 2022) and 1 other predicate after a 246-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Nov 20, 2024
- Review
- 246 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010954 (2001). 12 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 9 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK181000 SelectFlex 072 Neurovascular Access SystemQ'Apel · 2018
- 2 generations backK191664 SelectFlex 072 Neurovascular Access SystemQ'Apel Medical · 2019
- 1 generation backK211893 SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2021
- This deviceK240746 Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 7 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 6 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 5 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 4 generations backK142321 Benchmark Intracranial Access SystemPenumbra, Inc. · 2015
- 3 generations backK181000 SelectFlex 072 Neurovascular Access SystemQ'Apel · 2018
- 2 generations backK191664 SelectFlex 072 Neurovascular Access SystemQ'Apel Medical · 2019
- 1 generation backK211893 SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2021
- This deviceK240746 Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −7 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −6 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −5 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −4 | K142321 | Benchmark Intracranial Access System | Penumbra, Inc. | 2015 | — |
| −3 | K181000 | SelectFlex 072 Neurovascular Access System | Q'Apel | 2018 | — |
| −2 | K191664 | SelectFlex 072 Neurovascular Access System | Q'Apel Medical | 2019 | — |
| −1 | K211893 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | 2021 | — |
| 0 (this device) | K240746 | Neurovascular Access System Family | Q'Apel Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K212838 | Benchmark Intracranial Access SystemSummary page 5…Codes: QJP, DQY Regulatory Class: II III. PREDICATES Primary predicate • Benchmark Intracranial Access System, K212838 Secondary predicate • SelectFlex Neurovascular Access System Family, K211893 IV. DEVICE DESCRIPTION… | 2022 |
| * | K211893 | SelectFlex Neurovascular Access System FamilySummary page 5…Primary predicate • Benchmark Intracranial Access System, K212838 Secondary predicate • SelectFlex Neurovascular Access System Family, K211893 IV. DEVICE DESCRIPTION The subject Neurovascular Access System Family consists of sterile, single-use catheters and… | 2021 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K212838.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240746: Neurovascular Access System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240746
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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