Company · US
Penumbra, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
88510(k) clearances (4 in 12 months)
12recalls (2 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NRY | Catheter, Thrombus Retriever | 33 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 27 |
| DQY | Catheter, Percutaneous | 13 |
| HCG | Device, Neurovascular Embolization | 11 |
| QJP | Catheter, Percutaneous, Neurovasculature | 5 |
| GWG | Endoscope, Neurological | 4 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| DYB | Introducer, Catheter | 1 |
| ISD | Exerciser, Measuring | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 |
| QEX | Coronary Mechanical Thrombectomy With Aspiration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K262904 | INDIGO® Aspiration System Penumbra, Inc. | QEW |
| Jun 10, 2026 | K250690 | Penumbra System (Thunderbolt Aspiration Tubing) Penumbra, Inc. | NRY |
| Apr 24, 2026 | K260599 | INDIGO® Aspiration System INDIGO Link Penumbra, Inc. | QEW |
| Feb 5, 2026 | K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra, Inc. | QEW |
| Oct 16, 2025 | K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tub Penumbra, Inc. | QEW |
| Mar 14, 2025 | K250079 | Ruby XL System Penumbra, Inc. | KRD |
| Feb 13, 2025 | K242104 | Penumbra System (Reperfusion Catheter RED 72) Penumbra, Inc. | NRY |
| Dec 11, 2024 | K242033 | Access25 Delivery Microcatheter Penumbra, Inc. | QJP |
| Nov 20, 2024 | K242520 | Element Vascular Access System Penumbra, Inc. | DYB |
| Sep 25, 2024 | K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing Penumbra, Inc. | QEW |
| Sep 3, 2024 | K242319 | Indigo® Aspiration System Aspiration Catheter 6X Penumbra, Inc. | QEW |
| Jun 10, 2024 | K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter Penumbra, Inc. | QEW |
| Mar 27, 2024 | K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Penumbra, Inc. | QJP |
| Feb 2, 2024 | K240030 | Indigo® Aspiration System - Lightning® Flash Penumbra, Inc. | QEW |
| Oct 25, 2023 | K230284 | Penumbra LP Coil System Penumbra, Inc. | HCG |
| Feb 13, 2023 | K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing Penumbra, Inc. | QEW |
| Dec 20, 2022 | K222808 | Penumbra System (Reperfusion Catheter RED 43) Penumbra, Inc. | NRY |
| Dec 20, 2022 | K222358 | Indigo Aspiration System - Lightning Flash Penumbra, Inc. | QEW |
| Nov 4, 2022 | K221822 | BENCHMARK BMX81 Access System Penumbra, Inc. | QJP |
| Oct 4, 2022 | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Penumbra, Inc. | QEW |
| Aug 18, 2022 | K213390 | Benchmark BMX96 Access System Penumbra, Inc. | QJP |
| May 27, 2022 | K212838 | Benchmark Intracranial Access System Penumbra, Inc. | QJP |
| Aug 16, 2021 | K211654 | Penumbra System (Reperfusion Catheter RED 72) Penumbra, Inc. | NRY |
| Jul 1, 2021 | K211411 | Penumbra System (RED 68 Reperfusion Catheter) Penumbra, Inc. | NRY |
| May 20, 2021 | K203440 | Penumbra System (Reperfusion Catheter RED 62) Penumbra, Inc. | NRY |
| Feb 26, 2021 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Feb 9, 2021 | K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 Penumbra, Inc. | QEW |
| Nov 18, 2020 | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 Penumbra, Inc. | QEW |
| Aug 31, 2020 | K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) Penumbra, Inc. | NRY |
| Aug 19, 2020 | K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra, Inc. | QEW |
| Jun 11, 2020 | K201271 | Benchmark BMX96 Access System Penumbra, Inc. | DQY |
| May 28, 2020 | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Penumbra, Inc. | QEW |
| Apr 22, 2020 | K200771 | Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Mar 13, 2020 | K193244 | Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Feb 27, 2020 | K191946 | Penumbra System Penumbra JET 7X Penumbra, Inc. | NRY |
| Dec 20, 2019 | K192833 | Indigo Aspiration System Penumbra, Inc. | QEW |
| Nov 20, 2019 | K192955 | Penumbra LP Coil System Penumbra, Inc. | HCG |
| Aug 30, 2019 | K190719 | Artemis Eye System Penumbra, Inc. | GWG |
| Jun 16, 2019 | K190010 | Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. | NRY |
| Apr 26, 2019 | K190464 | Penumbra System 3D Revascularization Device Penumbra, Inc. | NRY |
| Mar 18, 2019 | K183296 | REAL Immersive System Penumbra, Inc. | ISD |
| Oct 12, 2018 | K182522 | Penumbra System (Modified 110 Aspiration Tubing) Penumbra, Inc. | NRY |
| Aug 17, 2018 | K173761 | Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. | NRY |
| Jun 20, 2018 | K180008 | Penumbra System Penumbra, Inc. | NRY |
| May 15, 2018 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister Penumbra, Inc. | QEW |
| May 3, 2018 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing Penumbra, Inc. | QEW |
| Apr 17, 2018 | K173614 | Penumbra Coil 400, Ruby Coil System, POD System Penumbra, Inc. | HCG |
| Mar 8, 2018 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister Penumbra, Inc. | QEW |
| Aug 14, 2017 | K171332 | Artemis Neuro Evacuation Device Penumbra, Inc. | GWG |
| Jul 19, 2017 | K170852 | POD Packing Coil Penumbra, Inc. | HCG |
Newest 50 of 88.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | Penumbra Inc. Brand Name: Penumbra System (RED 62 Reperfusion Catheter)
Product Name: Penumbra System (RED 62 Reperfusion Catheter)
Model/Catalog Number: THNDRRED62SKIT
Software Version: N/A
Product Description: Pr Open, Classified |
NRY | K203440 K250690 |
| Jul 21, 2026 | Penumbra, Inc. Penumbra System RED 68 Reperfusion Catheter
REF: RED68KIT Open, Classified |
NRY | K211411 |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Terminated |
NRY | K190010 K191946 +1 |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of t Terminated |
NRY | K190010 K191946 +1 |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the P Terminated |
NRY | K190010 K191946 +1 |
| Jan 18, 2021 | Penumbra Inc. Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers as Terminated |
NRY | K190010 K191946 +1 |
| Jun 22, 2017 | Penumbra Inc. Penumbra 3D Revascularization Device
It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the inte Terminated |
NRY | K162901 |
| Apr 12, 2011 | Penumbra Inc. Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA
The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endov Terminated |
HCG | K103305 |
| Nov 24, 2010 | Penumbra Inc. Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA. Terminated |
NRY | K072718 |
| Oct 5, 2009 | Penumbra Inc. Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA.
Indicated for t Terminated |
DQY | K082290 |
| Sep 24, 2009 | Penumbra Inc. Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA
Percutaneous Catheter, indicated for the introduction of interventional devices into the periphera Terminated |
DQY | K070970 |
| Sep 8, 2009 | Penumbra Inc. Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA.
Intended for the introduction of interventional devices into the pe Terminated |
DQY | K083125 |