510(k) Report

510(k) · Cleared

Cleared

Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]

K142870510(k) TraditionalCleared May 26, 2015237-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 26, 2015 as substantially equivalent to K121917 (Penumbra, Inc., 2012) after a 237-day review. Its family tree reaches back 7 generations to 2001. 42 later devices descend from it.

Decided
May 26, 2015
Review
237 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K003410 (2001). 9 ancestors in all, the oldest K003086 (2001). 42 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2001: 1 other ancestor2023: 4 descendants cleared2019: 1 descendant cleared2020: 6 descendants cleared2025: 8 descendants cleared2016: 2 descendants cleared2022: 4 descendants cleared2026: 7 descendants cleared2024: 6 descendants cleared2021: 2 descendants cleared2018: 2 descendants clearedK003410 · 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. · 2012200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K121917 · 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 · 7 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 5 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 4 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 3 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 2 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 1 generation backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
  8. This deviceK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
  9. Descendant · cites it directly · 27 of its ownK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
  10. Descendant · 2 generations on · 26 of its ownK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
  11. Descendant · 3 generations on · 22 of its ownK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
  12. Descendant · 4 generations on · 21 of its ownK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
  13. Descendant · 5 generations on · 14 of its ownK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2016: 22018: 22019: 12020: 62021: 22022: 42023: 42024: 62025: 82026: 7
2016high 8 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 42 · See all
  • K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016 · cites it directly27descendants
  • K161523INDIGO Aspiration SystemPenumbra, Inc. · 2016 · 2 generations on26descendants
  • K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc. · 2018 · 3 generations on22descendants
  • K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018 · 4 generations on21descendants
  • K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201820
201910
202060
202120
202240
202340
202460
202580
202670
FIG. 1 — Lineage of K142870, 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
*K121917Penumbra Embolectomy Aspiration System
Summary page 4
…tomy catheter Regulation Number: 21 CFR § 870.5150 Product Code: DXE Predicate Devices 510(k) Number / Clearance Date Name of Predicate Device Name of Manufacturer K 121917 [19Sep2012] Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) Penumbra, Inc. Page 1 of § 1.8…
Penumbra, Inc.2012—

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.201627
K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.202012
K192833Indigo Aspiration SystemPenumbra, Inc.20195
K223216Symphony Thrombectomy SystemTruvic Medical, Inc.20233
K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201
K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.20260
K250787Liberant Thrombectomy SystemMedtronic, Ireland20250
K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc.20230
K214114Prodigy Thrombectomy SystemTruvic Medical, 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 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K160533 (Penumbra, Inc., 2016) has gone furthest, with 27 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. 2015, 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?

The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries or the neurovasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K142870 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142870: Penumbra Embolectomy Aspiration System [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/K142870

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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