510(k) · Cleared
ClearedIndigo Aspiration System - Aspiration Catheter 12 and Separator 12
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 Nov 18, 2020 as substantially equivalent to K192981 (Penumbra, Inc., 2020) and 2 other predicates after a 55-day review. Its family tree reaches back 9 generations to 2001. 3 of the 31 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 18, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K003410 (2001). 30 ancestors in all, the oldest K832023 (1983). No later device cites it as a predicate yet. 3 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 2 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 1 generation backK192833 Indigo Aspiration SystemPenumbra, Inc. · 2019
- This deviceK202821 Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 3 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 2 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 1 generation backK192833 Indigo Aspiration SystemPenumbra, Inc. · 2019
- This deviceK202821 Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −7 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −6 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −5 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −4 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −3 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −2 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −1 | K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019 | — |
| 0 (this device) | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | Penumbra, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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.
3 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 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? (3)
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 |
|---|---|---|---|
| * | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Summary page 4…Name of Device Name of Manufacture Predicate Device K192981 Indigo Aspiration System – Aspiration Catheter 12… | 2020 |
| * | K192833 | Indigo Aspiration SystemSummary page 4…r 12 Penumbra, Inc. and Separator 12 Reference Device K192833 Indigo Aspiration System Penumbra, Inc. K180466 FlowT… | 2019 |
| * | K180466 | FlowTriever Retrieval/Aspiration SystemSummary page 4…nc. and Separator 12 Reference Device K192833 Indigo Aspiration System Penumbra, Inc. K180466 FlowTriever Retrieval/Aspiration System Inari Medical, Inc.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K192981.
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. 2020, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202821: Indigo Aspiration System - Aspiration Catheter 12 and Separator 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202821
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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