510(k) · Decided
DecidedINDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
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 Oct 4, 2022 as substantially equivalent to K180412 (Penumbra, Inc., 2018) after a 210-day review. Its family tree reaches back 10 generations to 2001. 1 of the 26 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 4, 2022
- Review
- 210 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010579 (2001). 25 ancestors in all, the oldest K883718 (1989). No later device cites it as a predicate yet. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 6 generations between
- 3 generations backK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- 2 generations backK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
- 1 generation backK180412 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine…Penumbra, Inc. · 2018
- This deviceK220683 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 9 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 8 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 7 generations backK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- 6 generations backK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- 5 generations backK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- 4 generations backK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
- 3 generations backK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- 2 generations backK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
- 1 generation backK180412 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine…Penumbra, Inc. · 2018
- This deviceK220683 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc. · 2022
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…6 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −9 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −8 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −7 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −6 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| −5 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| −4 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
| −3 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
| −2 | K163618 | INDIGO Aspiration System | Penumbra, Inc. | 2017 | — |
| −1 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and… | Penumbra, Inc. | 2018 | — |
| 0 (this device) | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | Penumbra, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 1 |
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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterSummary page 6…ÿ 789ÿÿ ÿÿ ÿ K220683 1.6 Predicate/Reference Device 510(k) Number ‘ Name of Device Predicate Device K180412 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) - Penumbra Engine Pump and Canister Reference Device K1636… | 2018 |
| † | K163618 | INDIGO Aspiration System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 6 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
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?
The INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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/K220683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220683: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220683
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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