510(k) · Cleared
ClearedIndigo 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 Dec 20, 2019 as substantially equivalent to K142870 (Penumbra, Inc., 2015) after a 79-day review. Its family tree reaches back 8 generations to 2001. 5 later devices descend from it.
- Decided
- Dec 20, 2019
- Review
- 79 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). 5 later devices descend from it, 4 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 deviceK192833 Indigo Aspiration SystemPenumbra, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK220270 Aspirex Thrombectomy SystemC.R. Bard, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242319 Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230356 Aspirex™ Thrombectomy SystemC.R. Bard, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK202821 Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK200771 Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K220270Aspirex Thrombectomy SystemC.R. Bard, Inc. · 2022 · cites it directly1descendant
- K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc. · 2024 · cites it directly0descendants
- K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc. · 2023 · 2 generations on0descendants
- K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc. · 2020 · cites it directly0descendants
- K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc. · 2020 · cites it directly0descendants
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) | K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019 | — |
| +1 | K220270 | Aspirex Thrombectomy System | C.R. Bard, Inc. | 2022 | — |
| +1 | K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | Penumbra, Inc. | 2024 | — |
| +2 | K230356 | Aspirex™ Thrombectomy System | C.R. Bard, Inc. | 2023 | — |
| +1 | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | Penumbra, Inc. | 2020 | — |
| +1 | K200771 | Indigo Aspiration System Lightning Aspiration Tubing | Penumbra, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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…Code: QEW 1.6 Predicate and Reference Devices 510(k) Number/Clearance Date Name of Device Name of Manufacture Predicate Device K142870 cleared on May 26, 2015 Penumbra Embolectomy Penumbra, Inc. Aspiration Syst… | 2015 |
| † | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | 2018 |
| † | K180466 | FlowTriever Retrieval/Aspiration System | 2018 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K220270 (C.R. Bard, Inc., 2022) has gone furthest, with 1 descendant 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. 2019, 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?
INDIGO Aspiration Catheters and Separators:
As part of the 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, and for the treatment of pulmonary embolism.
INDIGO Aspiration Tubing:
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192833: Indigo Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192833
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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