510(k) · Cleared
ClearedINDIGO® Aspiration System – INDIGO Link
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 Apr 24, 2026 as substantially equivalent to K231022 (Surmodics,Inc., 2023) after a 59-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Apr 24, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970657 (1997). 11 ancestors in all, the oldest K892410 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK970657 Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
- 6 generations backK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- 5 generations backK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- 4 generations backK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
- 3 generations backK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
- 2 generations backK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
- 1 generation backK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023
- This deviceK260599 INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970657 | Lmi Thrombectomy Catheter | Lucas Medical, Inc. | 1997 | — |
| −6 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −5 | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| −4 | K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020 | — |
| −3 | K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021 | — |
| −2 | K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 | — |
| −1 | K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023 | — |
| 0 (this device) | K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K231022 | Pounce™ Thrombectomy SystemSummary page 5…r: 21 CFR §870.5150 Product Code: QEW 3. Predicate and Reference Devices 510(k) Number Name of Device Predicate K231022 Pounce™ LP Thrombectomy System Reference K190464 Penumbra System® (3D Revascularization… | 2023 |
| † | K190464 | Penumbra System 3D Revascularization Device | 2019 |
| † | K162901 | Penumbra 3D Revascularization Device | 2017 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K231022.
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. 2026, 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, INDIGO Link is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system ≥ 2.5mm in diameter. INDIGO Link is…
Read the full statement (124 words)
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, INDIGO Link is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system ≥ 2.5mm in diameter. INDIGO Link is not intended for use in pulmonary arteries, coronaries, or the neurovasculature.
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 Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260599: INDIGO® Aspiration System – INDIGO Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260599
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026