510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Penumbra System (Reperfusion Catheter RED 62)

K203440510(k) TraditionalCleared May 20, 2021178-day reviewClass II21 CFR 870.1250Recalls 1

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

Penumbra, Inc. · NRY Catheter, Thrombus Retriever

Cleared on May 20, 2021 as substantially equivalent to K161640 (Penumbra, Inc., 2016) and 1 other predicate after a 178-day review. Its family tree reaches back 10 generations to 2001. 1 of the 18 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.

Decided
May 20, 2021
Review
178 days
Class
Class II
Product code
NRY
Recalls
1
Predicates
2

Its longest line of descent runs back 10 generations to K003410 (2001). 15 ancestors in all, the oldest K003086 (2001). 2 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor, 1 with a Class I recall12012: 1 other ancestor2014: 1 other ancestor2009: 1 other ancestor2001: 1 other ancestor2022: 1 descendant cleared2026: 1 descendant 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. · 2011K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016×2: 2 generations cleared close together, K160449 (2016), K161640 (2016) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor, 1 with a Class I recall13 generations back: 1 other ancestor5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 2 descendants K161640 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016K160449 · Penumbra System, Penumbra Pump MAX · Penumbra, Inc. · 2016K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K113163 · 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
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations between
  3. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  4. 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  5. 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  6. This deviceK203440 Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. · 2021
  7. Descendant · cites it directly · 1 of its ownK222808 Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc. · 2022
  8. Descendant · cites it directly · 0 of its ownK254276 Lynx Aspiration Catheter SystemQ’Apel Medical, Inc. · 2026
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 backK142458 Penumbra System ACEPenumbra, Inc. · 2015
  8. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  9. 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  10. 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  11. This deviceK203440 Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. · 2021

Class I recalls in this family

  • K162901 Penumbra 3D Revascularization Devicedirect predicate · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc. · 2022 · cites it directly1descendant
  • K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc. · 2026 · cites it directly0descendants
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—
−4K142458Penumbra System ACEPenumbra, Inc.2015—
−3K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.2016—
−2K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.2016—
−1K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.2016—
0 (this device)K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.2021—
+1K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.2022—
+1K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910
201210
201410
201711

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202610
FIG. 1 — Lineage of K203440, 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.

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 NRY device

  1. #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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? (2)

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
*K161640Penumbra System ACE 68 Reperfusion Catheter
Summary page 4
…Manufacturer Penumbra, K161640 Penumbra System ACE 68 Reperfusion Catheter Inc.…
Penumbra, Inc.2016—
*K162901Penumbra 3D Revascularization Device
Summary page 4
…K161640 Penumbra System ACE 68 Reperfusion Catheter Inc. Penumbra, K162901 Penumbra 3D Revascularization Device Inc.…
Penumbra, Inc.2017Class I

Also cleared against K161640: 5 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221
K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 24, 2026Class IIZ-3331-2026Under Investigation by firmDue to manufacturing issues reperfusion catheters may fracture.

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.

  • K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K222808 (Penumbra, Inc., 2022) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K161640.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · NRY

15in 2025

2007: 52008: 22009: 22010: 12011: 22012: 42014: 42015: 62016: 52017: 32018: 112019: 72020: 62021: 92022: 32023: 82024: 82025: 152026 (partial year): 14
2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007: 94 days median2012: 90 days median2014: 140 days median2015: 128 days median2016: 75 days median2017: 185 days median2018: 156 days median2019: 89 days median2020: 125 days median2021: 80 days median2022: 129 days median2023: 112 days median2024: 165 days median2025: 129 days median2026 (partial year): 147 days median
2007high 185 (2017) · low 75 (2016)2026

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

Recalls per year · NRY

4in 2020

2010: 12013: 12017: 42020: 4, 4 Class I2026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · NRY

565in 2025

2007: 132008: 182009: 572010: 2892011: 2632012: 3662013: 4052014: 4282015: 5982016: 4972017: 4322018: 4152019: 6502020: 7032021: 6882022: 5492023: 7112024: 6412025: 565
2007high 711 (2023) · low 13 (2007)2025

MAUDE reports naming product code NRY, 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
2007594013
20082—018
20092—057
20101—1289
20112—0263
20124900366
20130—1405
201441400428
201561280598
20165750497
201731854432
2018111560415
20197890650
202061254 (4)703
20219800688
202231290549
202381120711
202481650641
2025151290565
2026141472—

What is it indicated for?

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen…

Read the full statement (195 words)

Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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 K161640

5 other devices cite the same predicate.

  • K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc. · 2026
  • K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
  • K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc. · 20211 recall
  • K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker · 2019
  • K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018

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 NRY

The NRY category page

  • K262021Toro 71 Aspiration Catheter; Toro Aspiration TubingToro Neurovascular, Inc. · 2026
  • K263266Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2026
  • K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc. · 2026
  • K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd. · 2026
  • K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc. · 2026

https://510kreport.com/device/K203440 · printed Nov 5, 2026

Cite this page

510(k) Report. “K203440: Penumbra System (Reperfusion Catheter RED 62).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203440

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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