510(k) · Cleared
ClearedIndigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
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 Feb 9, 2021 as substantially equivalent to K193595 (Penumbra, Inc., 2020) after a 28-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Feb 9, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K003410 (2001). 13 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 2 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 1 generation backK193595 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc. · 2020
- This deviceK210083 Indigo System Aspiration Catheter 7, Indigo Aspiration System…Penumbra, Inc. · 2021
Show all 11 generations
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 10 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 9 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 8 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 7 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 6 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 5 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 4 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 3 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 2 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 1 generation backK193595 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc. · 2020
- This deviceK210083 Indigo System Aspiration Catheter 7, Indigo Aspiration System…Penumbra, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −10 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −9 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −8 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −7 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −6 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −5 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −4 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −3 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −2 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −1 | K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | Penumbra, Inc. | 2020 | — |
| 0 (this device) | K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7… | Penumbra, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Summary page 4…R §870.5150 Product Code: QEW 1.3 Predicate and Reference Device Information Indigo Aspiration System – Aspiration Catheter 7 and Separator 7 (K193595) and Indigo Aspiration System (K192833) 1.4 Device Description The INDIGO® Aspiration System is comprised of:… | 2020 |
| † | K192833 | Indigo Aspiration System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
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. 2021, 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/K210083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210083: Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210083
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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