510(k) · Cleared
ClearedIndigo Aspiration System - Lightning Flash
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, 2022 as substantially equivalent to K210323 (Penumbra, Inc., 2021) and 2 other predicates after a 138-day review. Its family tree reaches back 14 generations to 2001. 8 later devices descend from it.
- Decided
- Dec 20, 2022
- Review
- 138 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K003410 (2001). 25 ancestors in all, the oldest K010853 (2001). 8 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 10 generations between
- 3 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 2 generations backK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- 1 generation backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- This deviceK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK240030 Indigo® Aspiration System - Lightning® FlashPenumbra, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK252956 Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261800 Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
- Descendant · 2 generations on · 0 of its ownK260028 CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter…Argon Medical Devices, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 13 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 12 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 11 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 10 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 9 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 8 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 7 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 6 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 5 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 4 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 3 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 2 generations backK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- 1 generation backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- This deviceK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc. · 2024 · cites it directly2descendants
- K252956Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025 · cites it directly1descendant
- K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc. · 2024 · cites it directly1descendant
- K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026 · 2 generations on0descendants
- K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −13 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −12 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −11 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −10 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −9 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −8 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −7 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −6 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −5 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −4 | 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 | — |
| −2 | K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | Penumbra, Inc. | 2020 | — |
| −1 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021 | — |
| 0 (this device) | K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | 2022 | — |
| +1 | K240030 | Indigo® Aspiration System - Lightning® Flash | Penumbra, Inc. | 2024 | — |
| +1 | K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025 | — |
| +1 | K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with… | Argon Medical Devices, Inc. | 2024 | — |
| +2 | K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | 2026 | — |
| +2 | K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with… | Argon Medical Devices, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K210323 | Indigo Aspiration System - Lightning Aspiration TubingSummary page 5…ate and Reference Devices – Lightning Flash 510(k) Number Name of Device Lightning Flash Aspiration Tubing Predicate K210323 Indigo Aspiration System – Lightning Aspiration Tubing Reference K202821 Indigo Aspiration System – Aspiration Cathet… | 2021 |
| * | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Summary page 5…– Lightning Aspiration Tubing Reference K202821 Indigo Aspiration System – Aspiration Catheter 12 and Separator 12 Flash Aspiration Catheter Predicate K192981 Indigo Aspiration System – Aspiration Catheter 12 and Separator 12 Reference K202821 Indigo Aspiration System – Aspir… | 2020 |
| * | K111380 | Neuron Max SystemSummary page 5…ration System – Aspiration Catheter 12 and Separator 12 Reference K180466 FlowTriever Retrieval/Aspiration System Select Catheter (Accessory) Predicate K111380 Neuron MAX System K222358 P… | 2011 |
| † | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | 2020 |
| † | K180466 | FlowTriever Retrieval/Aspiration System | 2018 |
What descends from it? (8)
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 21 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 25 ancestors have a recall of any class.
- Of its descendants, K240030 (Penumbra, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K210323.
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. 2022, 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 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.
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.
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222358: Indigo Aspiration System - Lightning Flash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222358
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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