510(k) · Cleared
ClearedPenumbra Balloon Guide Catheter, Model 7.5F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · DQY Catheter, Percutaneous
Cleared on Apr 27, 2006 as substantially equivalent to K021899 (Concentric Medical, Inc., 2002) after a 133-day review. Its family tree reaches back 2 generations to 2001. 4 of the 109 devices in its family, counting itself, have a Class I recall. 106 later devices descend from it.
- Decided
- Apr 27, 2006
- Review
- 133 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010954 (2001). 106 later devices descend from it, 1 citing it directly. 4 of the 109 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 1 generation backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- This deviceK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- Descendant · cites it directly · 105 of its ownK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 88 of its ownK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 86 of its ownK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 61 of its ownK111380 Neuron Max SystemPenumbra, Inc. · 2011
- Descendant · 3 generations on · 27 of its ownK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 106 · See all- K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · cites it directly105descendants
- K082290Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · 2 generations on88descendants
- K083125Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · 2 generations on86descendants
- K111380Neuron Max SystemPenumbra, Inc. · 2011 · 2 generations on61descendants
- K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc. · 2018 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −1 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| 0 (this device) | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| +1 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| +2 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| +2 | K083125 | Neuron Select Catheter Size 070 | Penumbra, Inc. | 2008 | 1 |
| +2 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| +3 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K021899 | Concentric Balloon Guide Catheter, Model 90072Summary page 1…3223 Fax: 510-352-1766 tballenripenumbrainc. com Predicate Device Concentric Balloon Guide Catheter (K021899) Manufactured by Concentric Medical, Inc. Device Description The Penumbra Balloon Guide Catheter is a coaxial-lumen, braid-reinf… | 2002 |
What descends from it? (106)
See all 1061 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070970 | Neuron Support Catheter System, Model 5F/6F | 2007 | 105 |
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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 6 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 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K070970 (Penumbra, Inc., 2007) has gone furthest, with 105 descendants of its own.
- 4 other devices also cite its predicate K021899.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053491: Penumbra Balloon Guide Catheter, Model 7.5F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053491
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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