510(k) · Cleared
Recalled · 2009Neuron Select Catheter Size 070
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · DQY Catheter, Percutaneous
Cleared on Nov 21, 2008 as substantially equivalent to K070970 (Penumbra, Inc., 2007) after a 30-day review. Its family tree reaches back 4 generations to 2001. 4 of the 92 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it. It has been recalled once.
- Decided
- Nov 21, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010954 (2001). 5 ancestors in all, the oldest K010853 (2001). 86 later devices descend from it, 4 citing it directly. 4 of the 92 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 3 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 2 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 1 generation backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- This deviceK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008
- 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
- Descendant · cites it directly · 16 of its ownK142321 Benchmark Intracranial Access SystemPenumbra, Inc. · 2015
- Descendant · 2 generations on · 13 of its ownK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 86 · See all- 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
- K142321Benchmark Intracranial Access SystemPenumbra, Inc. · 2015 · cites it directly16descendants
- K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc. · 2016 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −3 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −2 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −1 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| 0 (this device) | K083125 | Neuron Select Catheter Size 070 | Penumbra, Inc. | 2008 | — |
| +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 | — |
| +1 | K142321 | Benchmark Intracranial Access System | Penumbra, Inc. | 2015 | — |
| +2 | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM | Tni Manufacturing, Inc. | 2016 | 1 |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 2 |
| 2021 | 6 | 0 |
| 2022 | 7 | 1 |
| 2023 | 8 | 0 |
| 2024 | 14 | 1 |
| 2025 | 10 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K070970 | Neuron Support Catheter System, Model 5F/6FSummary page 1…Fax: 510-814-8310 theresa.brandnerallen~penumbrainc.com Predicate Devices Neuron Intracranial Access System (K070970), manufactured by Penumbra, Inc. Device Description The Neuron Intracranial Access System has a Neuron Select Catheter 053 (pred… | 2007 |
What descends from it? (86)
See all 864 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2009 | Not classified | Z-2049-2009 | Process control | Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage. |
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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K111380 (Penumbra, Inc., 2011) has gone furthest, with 61 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. 2008, 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/K083125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083125: Neuron Select Catheter Size 070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083125
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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