510(k) · Cleared
Recalled · 2009Neuron Support Catheter System, Model 5F/6F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 17, 2007 as substantially equivalent to K053491 (Penumbra, Inc., 2006) and 1 other predicate after a 133-day review. Its family tree reaches back 3 generations to 2001. 4 of the 110 devices in its family, counting itself, have a Class I recall. 105 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2007
- Review
- 133 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010954 (2001). 4 ancestors in all, the oldest K010853 (2001). 105 later devices descend from it, 9 citing it directly. 4 of the 110 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 2 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 1 generation backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- This deviceK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007
- Descendant · cites it directly · 88 of its ownK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- Descendant · cites it directly · 86 of its ownK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · Recalled
- Descendant · cites it directly · 61 of its ownK111380 Neuron Max SystemPenumbra, Inc. · 2011
- Descendant · 2 generations on · 27 of its ownK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- Descendant · 3 generations on · 17 of its ownK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 105 · See all- K082290Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · cites it directly88descendants
- K083125Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · cites it directly86descendants
- K111380Neuron Max SystemPenumbra, Inc. · 2011 · cites it directly61descendants
- K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc. · 2018 · 2 generations on27descendants
- K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc. · 2021 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −2 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −1 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| 0 (this device) | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | — |
| +1 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| +1 | K083125 | Neuron Select Catheter Size 070 | Penumbra, Inc. | 2008 | 1 |
| +1 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| +2 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| +3 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 2 |
| 2021 | 6 | 0 |
| 2022 | 9 | 1 |
| 2023 | 11 | 0 |
| 2024 | 14 | 1 |
| 2025 | 10 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K053491 | Penumbra Balloon Guide Catheter, Model 7.5FSummary page 1…Fax: 510-352-1766 tballena)penumbrainc.com Predicate Devices - Penumbra Balloon Guide Catheter (K053491), manufactured by Penumbra, Inc. - Guider Softip Guiding Catheter XF 5F (K010853), manufactured by Boston Scientific Corporatio… | 2006 |
| * | K010853 | Guider Softip Guiding Catheter XF 5FSummary page 1…tballena)penumbrainc.com Predicate Devices - Penumbra Balloon Guide Catheter (K053491), manufactured by Penumbra, Inc. - Guider Softip Guiding Catheter XF 5F (K010853), manufactured by Boston Scientific Corporation Device Description The Neuron Intracranial Access System has a Neuron Delivery… | 2001 |
What descends from it? (105)
See all 1059 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082290 | Neuron Delivery Catheter 070 | 2008 | 88 |
| K083125 | Neuron Select Catheter Size 070 | 2008 | 86 |
| K111380 | Neuron Max System | 2011 | 61 |
| K082385 | Chaperon Guiding Catheter | 2008 | 17 |
| K093970 | Pica Catheter | 2010 | 5 |
| K100826 | Penumbra Catherer 025 | 2010 | 2 |
| K130649 | Silk Road Access Catheter | 2013 | 1 |
| K102418 | Reverse Medical Report Guide Catheter System | 2011 | 1 |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | 2024 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2009 | Not classified | Z-2313-2009 | Mixed-up of materials/components | Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery' |
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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 5 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 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K082290 (Penumbra, Inc., 2008) has gone furthest, with 88 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 NeuronTM 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/K070970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070970: Neuron Support Catheter System, Model 5F/6F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070970
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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