510(k) Report

510(k) · Cleared

Cleared

Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister

K180105510(k) SpecialCleared Mar 8, 201851-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 Mar 8, 2018 as substantially equivalent to K161523 (Penumbra, Inc., 2016) after a 51-day review. Its family tree reaches back 10 generations to 2001. 22 later devices descend from it.

Decided
Mar 8, 2018
Review
51 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K003410 (2001). 12 ancestors in all, the oldest K003086 (2001). 22 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2001: 1 other ancestor2018: 1 descendant cleared2020: 3 descendants cleared2024: 5 descendants cleared2025: 5 descendants cleared2026: 5 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant clearedReference device: K122756 · Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing · Penumbra, Inc. · 2012K003410 · 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. · 2015×2: 2 generations cleared close together, K160533 (2016), K161523 (2016) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 5 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants K161523 · INDIGO Aspiration System · Penumbra, Inc. · 2016K160533 · Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) · Penumbra, Inc. · 2016K142870 · 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−10−50+5
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations between
  3. 3 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  4. 2 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
  5. 1 generation backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
  6. This deviceK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
  7. Descendant · cites it directly · 21 of its ownK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
  8. Descendant · 2 generations on · 14 of its ownK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
  9. Descendant · 3 generations on · 11 of its ownK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
  10. Descendant · 4 generations on · 8 of its ownK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
  11. Descendant · 2 generations on · 2 of its ownK234073 ICE Aspiration SystemExpanse Medical, Inc. · 2024
Show all 10 generations
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 7 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 6 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 5 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 4 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
  8. 3 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  9. 2 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
  10. 1 generation backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
  11. This deviceK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2018: 12020: 32021: 12022: 12023: 12024: 52025: 52026: 5
2018high 5 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 22 · See all
  • K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018 · cites it directly21descendants
  • K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020 · 2 generations on14descendants
  • K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021 · 3 generations on11descendants
  • K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022 · 4 generations on8descendants
  • K234073ICE Aspiration SystemExpanse Medical, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−9K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−8K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−7K072718Penumbra SystemPenumbra, Inc.20071
−6K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
−5K113163Penumbra System MaxPenumbra, Inc.2011—
−4K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc.2012—
−3K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.2015—
−2K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.2016—
−1K161523INDIGO Aspiration SystemPenumbra, Inc.2016—
0 (this device)K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -…Penumbra, Inc.2018—
+1K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.2018—
+2K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.2020—
+3K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.2021—
+4K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.2022—
+2K234073ICE Aspiration SystemExpanse Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202030
202110
202210
202310
202450
202550
202650
FIG. 1 — Lineage of K180105, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K161523INDIGO Aspiration System
Summary page 4
…6 Predicate and Reference Devices 510(k) Number / Clearance Date Name of Device Name of Manufacturer Predicate Device K161523 cleared on July 1, 2016 Penumbra, Inc. Indigo Aspi…
Penumbra, Inc.2016—
†K122756Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/TubingPenumbra, Inc.2012—

Also cleared against K161523: 2 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821

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 17 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 12 ancestors have a recall of any class.
  • Of its descendants, K180939 (Penumbra, Inc., 2018) has gone furthest, with 21 descendants of its own.
  • 2 other devices also cite its predicate K161523.

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. 2018, 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 K161523

2 other devices cite the same predicate.

  • K213771Merlin Aspiration SystemMivi Neurovascular, 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/K180105 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180105: Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180105

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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