510(k) · Cleared
ClearedNeuron Max 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 Jul 19, 2011 as substantially equivalent to K070970 (Penumbra, Inc., 2007) and 2 other predicates after a 64-day review. Its family tree reaches back 5 generations to 2001. 4 of the 69 devices in its family, counting itself, have a Class I recall. 61 later devices descend from it.
- Decided
- Jul 19, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010954 (2001). 7 ancestors in all, the oldest K010853 (2001). 61 later devices descend from it, 10 citing it directly. 4 of the 69 devices in this family, counting this one, have a Class I recall.
- 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 deviceK111380 Neuron Max SystemPenumbra, Inc. · 2011
- Descendant · cites it directly · 27 of its ownK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- Descendant · 2 generations on · 17 of its ownK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
- Descendant · cites it directly · 13 of its ownK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 61 · See all- K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc. · 2018 · cites it directly27descendants
- K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc. · 2021 · 2 generations on17descendants
- K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc. · 2016 · cites it directly13descendants
- K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022 · cites it directly8descendants
- K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020 · 2 generations on8descendants
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) | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| +1 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| +2 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
| +1 | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM | Tni Manufacturing, Inc. | 2016 | 1 |
| +1 | K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | 2022 | — |
| +2 | K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 2 |
| 2021 | 5 | 0 |
| 2022 | 5 | 1 |
| 2023 | 7 | 0 |
| 2024 | 10 | 1 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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.
4 devices in this family have a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K070970 | Neuron Support Catheter System, Model 5F/6FSummary page 1…vices 510O(k) Number!/evc Name of Clearance Date Name of Predicate DeieManufacturer K070970 /17Aug2007 Neuron Intracranial Access System Penumbra, Inc. 053, Model 5F/6F… | 2007 |
| * | K082290 | Neuron Delivery Catheter 070Summary page 1…DeieManufacturer K070970 /17Aug2007 Neuron Intracranial Access System Penumbra, Inc. 053, Model 5F/6F K082290 /310Oct2008 Neuron Delivery Catheter 070 Penumbra, Inc. K083 125 /2 I Nov2008 Neuron Select Cathe… | 2008 |
| * | K083125 | Neuron Select Catheter Size 070Summary page 1…Penumbra, Inc. 053, Model 5F/6F K082290 /310Oct2008 Neuron Delivery Catheter 070 Penumbra, Inc. K083 125 /2 I Nov2008 Neuron Select Catheter 070 Penumbra, Inc.… | 2008 |
What descends from it? (61)
See all 6110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access… | 2018 | 27 |
| K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM | 2016 | 13 |
| K222358 | Indigo Aspiration System - Lightning Flash | 2022 | 8 |
| K201271 | Benchmark BMX96 Access System | 2020 | 1 |
| K200910 | BOSS Balloon Guide Catheter | 2020 | 1 |
| K182918 | Ballast 088 Long Sheath | 2019 | 1 |
| K151396 | MIVI Mi-AXUS Guide Catheter | 2015 | 1 |
| K253359 | Zenith Distal Access Long Sheath | 2026 | 0 |
| K222603 | 6F Wallaby Long Sheath | 2023 | 0 |
| K192804 | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide… Class I | 2020 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 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, K180169 (Imperative Care, Inc., 2018) has gone furthest, with 27 descendants of its own.
- 8 other devices also cite its predicate K070970.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111380: Neuron Max System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111380
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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