Data / Medical devices / United States / Penumbra Inc.
Penumbra Inc.: FDA-registered device maker in Roseville, CA, United States, 86 510(k) clearances
Penumbra Inc. is registered with the FDA (registration 3016591327) in Roseville, CA, United States. It lists 12 device types. The FDA files 86 510(k) clearances under its listings, the newest dated October 15, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016591327
- Address
- 630 Roseville Parkway, Roseville, CA, United States, 95747
- Owner or operator
- PENUMBRA, INC. (9072336)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- April 19, 2005
- Registered through
- 2027
- Brand names listed
- ASPIRATION PUMP, Access25 Delivery Microcatheter, Apollo System, Artemis Neuro Evacuation Device, BMX 81 Delivery Catheter, Benchmark BMX96 Access System, Benchmark BMX96 System, Benchmark Intracranial Access System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Thrombus Retriever | NRY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Coronary Mechanical Thrombectomy With Aspiration | QEX | 2 | Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 15, 2026 | K262904 | INDIGO® Aspiration System | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 10, 2026 | K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 24, 2026 | K260599 | INDIGO® Aspiration System INDIGO Link | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 5, 2026 | K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 16, 2025 | K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 14, 2025 | K250079 | Ruby XL System | KRD | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 13, 2025 | K242104 | Penumbra System (Reperfusion Catheter RED 72) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 11, 2024 | K242033 | Access25 Delivery Microcatheter | QJP | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 20, 2024 | K242520 | Element Vascular Access System | DYB | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| September 25, 2024 | K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| September 3, 2024 | K242319 | Indigo® Aspiration System Aspiration Catheter 6X | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 10, 2024 | K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 27, 2024 | K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | QJP | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 2, 2024 | K240030 | Indigo® Aspiration System - Lightning® Flash | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 25, 2023 | K230284 | Penumbra LP Coil System | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 13, 2023 | K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 20, 2022 | K222808 | Penumbra System (Reperfusion Catheter RED 43) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 20, 2022 | K222358 | Indigo Aspiration System - Lightning Flash | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 4, 2022 | K221822 | BENCHMARK BMX81 Access System | QJP | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 4, 2022 | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | QEW | Unknown | Penumbra, Inc. | accessdata.fda.gov |
| August 18, 2022 | K213390 | Benchmark BMX96 Access System | QJP | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 27, 2022 | K212838 | Benchmark Intracranial Access System | QJP | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 16, 2021 | K211654 | Penumbra System (Reperfusion Catheter RED 72) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 1, 2021 | K211411 | Penumbra System (RED 68 Reperfusion Catheter) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 20, 2021 | K203440 | Penumbra System (Reperfusion Catheter RED 62) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 26, 2021 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 9, 2021 | K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 31, 2020 | K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 19, 2020 | K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 11, 2020 | K201271 | Benchmark BMX96 Access System | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 28, 2020 | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 22, 2020 | K200771 | Indigo Aspiration System Lightning Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 13, 2020 | K193244 | Indigo Aspiration System Lightning Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 27, 2020 | K191946 | Penumbra System Penumbra JET 7X | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 20, 2019 | K192833 | Indigo Aspiration System | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 20, 2019 | K192955 | Penumbra LP Coil System | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 16, 2019 | K190010 | Penumbra System Reperfusion Catheter JET 7 | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 26, 2019 | K190464 | Penumbra System 3D Revascularization Device | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182522 | Penumbra System (Modified 110 Aspiration Tubing) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 17, 2018 | K173761 | Penumbra System Reperfusion Catheter JET 7 | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 20, 2018 | K180008 | Penumbra System | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 15, 2018 | K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 3, 2018 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 17, 2018 | K173614 | Penumbra Coil 400, Ruby Coil System, POD System | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 8, 2018 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 14, 2017 | K171332 | Artemis Neuro Evacuation Device | GWG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 19, 2017 | K170852 | POD Packing Coil | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 24, 2017 | K163618 | INDIGO Aspiration System | QEX | Unknown | Penumbra, Inc. | accessdata.fda.gov |
| April 20, 2017 | K162901 | Penumbra 3D Revascularization Device | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| September 26, 2016 | K161506 | Penumbra Aspiration System | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 12, 2016 | K161640 | Penumbra System ACE 68 Reperfusion Catheter | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 1, 2016 | K161523 | INDIGO Aspiration System | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 12, 2016 | K161064 | Penumbra System ACE 68 Reperfusion Catheter | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 25, 2016 | K160449 | Penumbra System, Penumbra Pump MAX | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 24, 2016 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 20, 2016 | K160832 | Penumbra Smart Coil | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 17, 2016 | K152699 | Apollo System | GWG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| January 13, 2016 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 2, 2015 | K152840 | Lantern Delivery Microcatheter | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 6, 2015 | K151623 | Penumbra System 110 Aspiration Tubing | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 10, 2015 | K151572 | Penumbra Smart Coil | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 26, 2015 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 22, 2015 | K142458 | Penumbra System ACE | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| March 18, 2015 | K143218 | Penumbra Smart Coil | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| January 26, 2015 | K142321 | Benchmark Intracranial Access System | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 3, 2014 | K141134 | POD SYSTEM | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 13, 2014 | K133317 | PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| January 17, 2014 | K132931 | APOLLO SYSTEM | GWG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 20, 2012 | K122772 | PENUMBRA DDC CATHETERS | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 2, 2012 | K122756 | PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING | JCX | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| September 19, 2012 | K121917 | PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 2, 2012 | K120330 | PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 23, 2011 | K113163 | PENUMBRA SYSTEM MAX | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 19, 2011 | K111380 | NEURON MAX SYSTEM | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| January 26, 2011 | K103305 | PENUMBRA EMBOLIZATION COIL SYSTEM | HCG | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| July 13, 2010 | K100826 | PENUMBRA CATHERER 025 | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 21, 2010 | K100769 | PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| January 15, 2010 | K093970 | PICA CATHETER | LIT | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| September 21, 2009 | K090752 | PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| November 21, 2008 | K083125 | NEURON SELECT CATHETER SIZE 070 | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| October 31, 2008 | K082290 | NEURON DELIVERY CATHETER 070 | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| December 28, 2007 | K072718 | PENUMBRA SYSTEM | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 17, 2007 | K070970 | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 27, 2006 | K053491 | PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| August 17, 2005 | K051758 | PENUMBRA ASPIRATION PUMP, MODEL 115V | BTA | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Catheter, Thrombus Retriever
- All makers of Catheter, Percutaneous
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Introducer, Catheter
- All makers of Device, Vascular, For Promoting Embolization
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.