510(k) · Cleared
ClearedPenumbra Embolectomy Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Sep 19, 2012 as substantially equivalent to K072718 (Penumbra, Inc., 2007) and 3 other predicates after a 79-day review. Its family tree reaches back 6 generations to 2001. 43 later devices descend from it.
- Decided
- Sep 19, 2012
- Review
- 79 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K003410 (2001). 8 ancestors in all, the oldest K003086 (2001). 43 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 4 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 3 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 2 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 1 generation backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- This deviceK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- Descendant · cites it directly · 42 of its ownK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- Descendant · 2 generations on · 27 of its ownK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- Descendant · 3 generations on · 26 of its ownK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- Descendant · 4 generations on · 22 of its ownK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- Descendant · 5 generations on · 21 of its ownK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015 · cites it directly42descendants
- K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016 · 2 generations on27descendants
- K161523INDIGO Aspiration SystemPenumbra, Inc. · 2016 · 3 generations on26descendants
- K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc. · 2018 · 4 generations on22descendants
- K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −4 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −3 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −2 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −1 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| 0 (this device) | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| +1 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| +2 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| +3 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| +4 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| +5 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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 QEW? 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K100691 | FDA’s K100691 is Omni V SBRT Positioning System, Model RT-4500 Our reading of the summary gave K100691, FDA’s number for Omni V SBRT Positioning System, Model RT-4500 (Bionix Development Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Merit Embolectomy Catheter”. Kept off the family tree. | 2010 |
| * | K072718 | Penumbra SystemSummary page 1…Medical K10069/ 1Ma20 I eritEmblecomy athterSystems, Inc. K072718 / 2813ec2007 Penumbra System Penumbra, Inc. K090752 / 21 Sep2009 Penumbra Syste… | 2007 |
| * | K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…Summary page 1…I eritEmblecomy athterSystems, Inc. K072718 / 2813ec2007 Penumbra System Penumbra, Inc. K090752 / 21 Sep2009 Penumbra System 054 Penumbra, Inc. K100769/ 2May2OlO Penumbra Syst… | 2009 |
| * | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Summary page 1…Penumbra System Penumbra, Inc. K090752 / 21 Sep2009 Penumbra System 054 Penumbra, Inc. K100769/ 2May2OlO Penumbra System Separator Flex [026, 032, Penumbra, Inc. ________________ 041, 054]… | 2010 |
| * | K113163 | Penumbra System MaxSummary page 1…Penumbra System Separator Flex [026, 032, Penumbra, Inc. ________________ 041, 054] _ ______ FK113163 /23Nov20 11 Penumbra System MAX Penumbra, Inc. 9.8 Device Description The… | 2011 |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | 2015 | 42 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K142870 (Penumbra, Inc., 2015) has gone furthest, with 42 descendants of its own.
- 6 other devices also cite its predicate K072718.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121917: Penumbra Embolectomy Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121917
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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