Chrysalis Intelligence · Sponsors · Penumbra, Inc.

Penumbra, Inc.

Alameda, CA, US · 34 510(k) clearances · 4 recalls (4 Class I)

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Total clearances
34
2020-02-27 → 2026-06-10
Last 12 months
4
Product codes
7
Most recent
2026-06-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 17 2026-04-24
NRY Catheter, Thrombus Retriever Class II Cardiovascular 8 2026-06-10
QJP — — — 5 2024-12-11
KRD — — — 1 2025-03-14
DYB Introducer, Catheter Class II Cardiovascular 1 2024-11-20
HCG — — — 1 2023-10-25
DQY — — — 1 2020-06-11
Safety

Recalls (4)

Class I (serious)
4
Risk of injury / death
Total recalls
4
Currently ongoing
0
Most recent
2020-12-15
DateSeverityStatusRecall # ProductCodeReason
2020-12-15 Class I Terminated Z-0851-2021 Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132… — The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in p…
2020-12-15 Class I Terminated Z-0850-2021 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Re… — The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in p…
2020-12-15 Class I Terminated Z-0849-2021 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperf… — The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in p…
2020-12-15 Class I Terminated Z-0848-2021 Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (J… — The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in p…
Filings

All 510(k) clearances (34)

Date K-number Device Code Class Specialty
2026-06-10 K250690 Penumbra System (Thunderbolt Aspiration Tubing) NRY Class II Cardiovascular
2026-04-24 K260599 INDIGO® Aspiration System – INDIGO Link QEW Class II Cardiovascular
2026-02-05 K251949 INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK QEW Class II Cardiovascular
2025-10-16 K252612 INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing QEW Class II Cardiovascular
2025-03-14 K250079 Ruby XL System KRD — —
2025-02-13 K242104 Penumbra System (Reperfusion Catheter RED 72) NRY Class II Cardiovascular
2024-12-11 K242033 Access25™ Delivery Microcatheter QJP — —
2024-11-20 K242520 Element Vascular Access System DYB Class II Cardiovascular
2024-09-25 K242075 Indigo® Aspiration System – Lightning Bolt Aspiration Tubing QEW Class II Cardiovascular
2024-09-03 K242319 Indigo® Aspiration System – Aspiration Catheter 6X QEW Class II Cardiovascular
2024-06-10 K241399 Indigo® Lightning Flash Aspiration System – Select +™ Catheter QEW Class II Cardiovascular
2024-03-27 K233201 MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) QJP — —
2024-02-02 K240030 Indigo® Aspiration System - Lightning® Flash QEW Class II Cardiovascular
2023-10-25 K230284 Penumbra LP Coil System HCG — —
2023-02-13 K223186 Indigo® Aspiration System – Lightning Bolt Aspiration Tubing QEW Class II Cardiovascular
2022-12-20 K222808 Penumbra System (Reperfusion Catheter RED 43) NRY Class II Cardiovascular
2022-12-20 K222358 Indigo Aspiration System - Lightning Flash QEW Class II Cardiovascular
2022-11-04 K221822 BENCHMARK BMX81 Access System QJP — —
2022-10-04 K220683 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) QEW Class II Cardiovascular
2022-08-18 K213390 Benchmark BMX96 Access System QJP — —
2022-05-27 K212838 Benchmark Intracranial Access System QJP — —
2021-08-16 K211654 Penumbra System (Reperfusion Catheter RED 72) NRY Class II Cardiovascular
2021-07-01 K211411 Penumbra System (RED 68 Reperfusion Catheter) NRY Class II Cardiovascular
2021-05-20 K203440 Penumbra System (Reperfusion Catheter RED 62) NRY Class II Cardiovascular
2021-02-26 K210323 Indigo Aspiration System - Lightning Aspiration Tubing QEW Class II Cardiovascular
2021-02-09 K210083 Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 QEW Class II Cardiovascular
2020-11-18 K202821 Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 QEW Class II Cardiovascular
2020-08-31 K202251 Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) NRY Class II Cardiovascular
2020-08-19 K193595 Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 QEW Class II Cardiovascular
2020-06-11 K201271 Benchmark BMX96 Access System DQY — —
2020-05-28 K192981 Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 QEW Class II Cardiovascular
2020-04-22 K200771 Indigo Aspiration System Lightning Aspiration Tubing QEW Class II Cardiovascular
2020-03-13 K193244 Indigo Aspiration System – Lightning Aspiration Tubing QEW Class II Cardiovascular
2020-02-27 K191946 Penumbra System Penumbra JET 7X NRY Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence