510(k) · Cleared
ClearedPenumbra Embolectomy Aspiration System (INDIGOTM 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 May 24, 2016 as substantially equivalent to K142870 (Penumbra, Inc., 2015) after a 96-day review. Its family tree reaches back 8 generations to 2001. 27 later devices descend from it.
- Decided
- May 24, 2016
- Review
- 96 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003410 (2001). 10 ancestors in all, the oldest K003086 (2001). 27 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 5 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 4 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 3 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 2 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 1 generation backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- This deviceK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- Descendant · cites it directly · 26 of its ownK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- Descendant · 2 generations on · 22 of its ownK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- Descendant · 3 generations on · 21 of its ownK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- Descendant · 4 generations on · 14 of its ownK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- Descendant · 5 generations on · 11 of its ownK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K161523INDIGO Aspiration SystemPenumbra, Inc. · 2016 · cites it directly26descendants
- K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc. · 2018 · 2 generations on22descendants
- K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018 · 3 generations on21descendants
- K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020 · 4 generations on14descendants
- K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −6 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −5 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −4 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −3 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −2 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −1 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| 0 (this device) | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| +1 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| +2 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| +3 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
| +4 | K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | Penumbra, Inc. | 2020 | — |
| +5 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Summary page 4…Name of Name of Device Clearance Date Manufacturer Predicate Device K142870[26May2015] Penumbra Embolectomy Aspiration System Penu… | 2015 |
| † | K121917 | Penumbra Embolectomy Aspiration System | 2012 |
| † | K122756 | Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing | 2012 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161523 | INDIGO Aspiration System | 2016 | 26 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K161523 (Penumbra, Inc., 2016) has gone furthest, with 26 descendants of its own.
- 8 other devices also cite its predicate K142870.
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. 2016, 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?
As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.
As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160533: Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160533
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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