510(k) Report

510(k) · Cleared

Cleared

INDIGO Aspiration System

K161523510(k) SpecialCleared Jul 1, 201629-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 Jul 1, 2016 as substantially equivalent to K160533 (Penumbra, Inc., 2016) after a 29-day review. Its family tree reaches back 9 generations to 2001. 26 later devices descend from it.

Decided
Jul 1, 2016
Review
29 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K003410 (2001). 11 ancestors in all, the oldest K003086 (2001). 26 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2001: 1 other ancestor2018: 2 descendants cleared2020: 4 descendants cleared2022: 2 descendants cleared2021: 2 descendants cleared2024: 5 descendants cleared2025: 5 descendants cleared2026: 5 descendants cleared2023: 1 descendant clearedReference device: K100826 · Penumbra Catherer 025 · Penumbra, Inc. · 2010Reference device: K082290 · Neuron Delivery Catheter 070 · Penumbra, Inc. · 2008 · recalledK003410 · 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. · 2015K160533 · Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) · Penumbra, Inc. · 2016200020052010201520202025
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 5 descendants7 generations forward: 4 descendants K160533 · 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−50+5
  1. Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 5 generations between
  3. 3 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
  4. 2 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  5. 1 generation backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
  6. This deviceK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
  7. Descendant · cites it directly · 22 of its ownK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
  8. Descendant · 2 generations on · 21 of its ownK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
  9. Descendant · 3 generations on · 14 of its ownK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
  10. Descendant · 4 generations on · 11 of its ownK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
  11. Descendant · 5 generations on · 8 of its ownK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
Show all 9 generations
  1. Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 3 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
  8. 2 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  9. 1 generation backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
  10. This deviceK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2018: 22020: 42021: 22022: 22023: 12024: 52025: 52026: 5
2018high 5 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 26 · See all
  • K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc. · 2018 · cites it directly22descendants
  • K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018 · 2 generations on21descendants
  • K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020 · 3 generations on14descendants
  • K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021 · 4 generations on11descendants
  • K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
202040
202120
202220
202310
202450
202550
202650
FIG. 1 — Lineage of K161523, 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
*K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
Summary page 5
…Name of 510(k) Number Clearance Date Name of Predicate Device Manufacturer K160533 May 24, 2016 Separator 8 Penumbra, Inc. Referen…
Penumbra, Inc.2016—
†K100826Penumbra Catherer 025Penumbra, Inc.2010—
†K082290Neuron Delivery Catheter 070Penumbra, Inc.20081

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc.201822
K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201
K213771Merlin Aspiration SystemMivi Neurovascular, Inc.20220

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 15 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • Of its descendants, K180105 (Penumbra, Inc., 2018) has gone furthest, with 22 descendants of its own.

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. 2016, 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 Pump MAX.

Penumbra Pump MAX:

The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.

Indications for use as stated in the FDA summary.

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/K161523 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161523: 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/K161523

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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