510(k) · Decided
DecidedINDIGO Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · QEX Coronary Mechanical Thrombectomy With Aspiration
Cleared on May 24, 2017 as substantially equivalent to K161506 (Penumbra, Inc., 2016) after a 153-day review. Its family tree reaches back 8 generations to 2001. 1 of the 26 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 24, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- QEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010579 (2001). 23 ancestors in all, the oldest K883718 (1989). 2 later devices descend from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 7 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 6 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 5 generations backK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- 4 generations backK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- 3 generations backK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- 2 generations backK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
- 1 generation backK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- This deviceK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK180412 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine…Penumbra, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK220683 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…4 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −7 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −6 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −5 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −4 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| −3 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| −2 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
| −1 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K163618 | INDIGO Aspiration System | Penumbra, Inc. | 2017 | — |
| +1 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and… | Penumbra, Inc. | 2018 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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.
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 QEX device
- #1 K253407 NeVa PV Thrombectomy Devicescore 11.9 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K161506 | Penumbra Aspiration SystemSummary page 5…Name of Clearance Date Name of Predicate Device Number Manufacturer K161506 September 26, 2016 Penumbra Aspiration System Penumbra, Inc.… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | 2018 | 1 |
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 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180412 (Penumbra, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QEX devicesQEX Coronary Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QEX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEX
Too few QEX 510(k)s in any year since 2007 to give a median.
Recalls per year · QEX
No recall names QEX since 2007.
Adverse event reports per year · QEX
23in 2025
MAUDE reports naming product code QEX, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 1 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
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.
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/K163618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163618: INDIGO Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163618
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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