510(k) Report

510(k) · Cleared

Cleared

Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

K192981510(k) TraditionalCleared May 28, 2020217-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Penumbra, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on May 28, 2020 as substantially equivalent to K142870 (Penumbra, Inc., 2015) after a 217-day review. Its family tree reaches back 8 generations to 2001. 12 later devices descend from it.

Decided
May 28, 2020
Review
217 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K003410 (2001). 10 ancestors in all, the oldest K003086 (2001). 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2001: 1 other ancestor2025: 4 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared2024: 3 descendants cleared2026: 3 descendants clearedReference device: K161523 · INDIGO Aspiration System · Penumbra, Inc. · 2016Reference device: K180939 · Indigo Aspiration System - Modified 110 Aspiration Tubing · Penumbra, Inc. · 2018Reference device: K180466 · FlowTriever Retrieval/Aspiration System · Inari Medical, Inc. · 2018K003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalledK030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K113163 · Penumbra System Max · Penumbra, Inc. · 2011K121917 · Penumbra Embolectomy Aspiration System · Penumbra, Inc. · 2012K142870 · Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] · Penumbra, Inc. · 2015200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants K142870 · Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] · Penumbra, Inc. · 2015K121917 · Penumbra Embolectomy Aspiration System · Penumbra, Inc. · 2012K113163 · Penumbra System Max · Penumbra, Inc. · 2011K100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalled−50
  1. Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 5 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 4 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 3 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 2 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
  8. 1 generation backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  9. This deviceK192981 Indigo System Aspiration Catheter 12, Indigo Aspiration System…Penumbra, Inc. · 2020
  10. Descendant · cites it directly · 8 of its ownK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
  11. Descendant · 2 generations on · 2 of its ownK240030 Indigo® Aspiration System - Lightning® FlashPenumbra, Inc. · 2024
  12. Descendant · 2 generations on · 1 of its ownK252956 Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
  13. Descendant · 2 generations on · 1 of its ownK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
  14. Descendant · 3 generations on · 0 of its ownK261800 Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2020: 12022: 12024: 32025: 42026: 3
2020high 4 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 12 · See all
  • K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022 · cites it directly8descendants
  • K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc. · 2024 · 2 generations on2descendants
  • K252956Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025 · 2 generations on1descendant
  • K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc. · 2024 · 2 generations on1descendant
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−7K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−6K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−5K072718Penumbra SystemPenumbra, Inc.20071
−4K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
−3K113163Penumbra System MaxPenumbra, Inc.2011—
−2K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc.2012—
−1K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.2015—
0 (this device)K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.2020—
+1K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.2022—
+2K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.2024—
+2K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.2025—
+2K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with…Argon Medical Devices, Inc.2024—
+3K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
202430
202540
202630
FIG. 1 — Lineage of K192981, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Summary page 4
…QEW 1.6 Predicate and Reference Devices 510(k) Number Name of Device Name of Manufacture Predicate Device K142870 Indigo Aspiration System – Aspiration Catheter 8 and…
Penumbra, Inc.2015—
†K161523INDIGO Aspiration SystemPenumbra, Inc.2016—
†K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.2018—
†K180466FlowTriever Retrieval/Aspiration SystemInari Medical, Inc.2018—

Also cleared against K142870: 8 other devices →

What descends from it? (12)

See all 12

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228
K251070Akura Thrombectomy SystemAkura Medical20250
K250787Liberant Thrombectomy SystemMedtronic, Ireland20250
K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200

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 19 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K222358 (Penumbra, Inc., 2022) has gone furthest, with 8 descendants of its own.
  • 8 other devices also cite its predicate K142870.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · QEW

14in 2025

2008: 22009: 22012: 12013: 22014: 22015: 42016: 42017: 22018: 142019: 82020: 162021: 112022: 122023: 232024: 142025: 142026 (partial year): 10
2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2015: 88 days median2016: 63 days median2018: 61 days median2019: 51 days median2020: 105 days median2021: 60 days median2022: 140 days median2023: 102 days median2024: 65 days median2025: 58 days median2026 (partial year): 74 days median
2007high 140 (2022) · low 51 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEW

7in 2022

2022: 7, 7 Class I
2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2019: 332020: 1972021: 3222022: 1252023: 1652024: 1622025: 207
2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20092—00
20100—00
20110—00
20121—00
20132—00
20142—00
201548800
201646300
20172—00
2018146100
2019851033
2020161050197
202111600322
2022121407 (7)125
2023231020165
202414650162
202514580207
202610740—

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.

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.

Also cleared against K142870

8 other devices cite the same predicate.

  • K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc. · 2026
  • K250787Liberant Thrombectomy SystemMedtronic, Ireland · 2025
  • K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc. · 2023
  • K223216Symphony Thrombectomy SystemTruvic Medical, Inc. · 2023
  • K214114Prodigy Thrombectomy SystemTruvic Medical, Inc. · 2022
  • K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc. · 2020

More from Penumbra, Inc.

88 FDA decisions under this applicant name. See the company

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc. · 20261 recall
  • K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026
  • K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc. · 2026
  • K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt…Penumbra, Inc. · 2025

Recent decisions in QEW

The QEW category page

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
  • K261523Vertex™ Thrombectomy SystemJupiter Endovascular · 2026

https://510kreport.com/device/K192981 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192981: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192981

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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