Penumbra, Inc.: FDA filings under this applicant name
FDA lists 87 510(k) clearances under the applicant name “Penumbra, Inc.” (first 2005, latest 2026), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 109 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 66 |
| 2013 | 0 | — |
| 2014 | 3 | 121 |
| 2015 | 7 | 128 |
| 2016 | 9 | 96 |
| 2017 | 4 | 136 |
| 2018 | 7 | 89 |
| 2019 | 6 | 95 |
| 2020 | 8 | 82 |
| 2021 | 5 | 56 |
| 2022 | 6 | 174 |
| 2023 | 2 | 194 |
| 2024 | 7 | 71 |
| 2025 | 3 | 60 |
| 2026 | 3 | 225 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Penumbra, Inc. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 26 | 26 |
| NRY | Catheter, Thrombus Retriever | 25 | 25 |
| DQY | Catheter, Percutaneous | 10 | 10 |
| HCG | Device, Neurovascular Embolization | 10 | 10 |
| QJP | Catheter, Percutaneous, Neurovasculature | 5 | 5 |
| GWG | Endoscope, Neurological | 4 | 4 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
Plus 3 more product codes.
Review panels
- Neurology (44)
- Cardiovascular (40)
- General and Plastic Surgery (2)
- Physical Medicine (1)
Most recent Penumbra, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | NRY | 2026-06-10 | 460 |
| K260599 | INDIGO® Aspiration System INDIGO Link | QEW | 2026-04-24 | 59 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | QEW | 2026-02-05 | 225 |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | QEW | 2025-10-16 | 58 |
| K250079 | Ruby XL System | KRD | 2025-03-14 | 60 |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | NRY | 2025-02-13 | 210 |
| K242033 | Access25 Delivery Microcatheter | QJP | 2024-12-11 | 153 |
| K242520 | Element Vascular Access System | DYB | 2024-11-20 | 89 |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | QEW | 2024-09-25 | 71 |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6X | QEW | 2024-09-03 | 29 |
77 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 8 recall events; 1 initiated in the last five years. Most recent: 2026-06-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Penumbra, Inc. is the lead sponsor of 25 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07107022: Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS). (Recruiting, started 2025-11-01)
- NCT06747117: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) (Recruiting, started 2025-05-18)
- NCT06446024: Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan (Completed, started 2023-12-07)
- NCT05684796: Comparison of Two Pulmonary Embolism Treatments (Completed, started 2023-11-27)
- NCT05437055: THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing (Completed, started 2022-08-11)
SEC filings
Penumbra Inc (PEN): EDGAR filings, CIK 1321732. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Penumbra, Inc.?
FDA lists 87 510(k) clearances under the applicant name “Penumbra, Inc.” (first 2005, latest 2026), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Penumbra, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Penumbra, Inc. is 94 days. Since 2017: 109 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Penumbra, Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 26); NRY (Catheter, Thrombus Retriever, 25); DQY (Catheter, Percutaneous, 10).
Next steps
- See all 87 Penumbra, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Penumbra, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.