Neuwave Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Neuwave Medical, Inc.” (first 2010, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 149 days. Since 2017 the median was 164 days, against 127 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 | 2 | 105 |
| 2013 | 1 | 149 |
| 2014 | 0 | — |
| 2015 | 1 | 150 |
| 2016 | 2 | 40 |
| 2017 | 2 | 78 |
| 2018 | 1 | 317 |
| 2019 | 1 | 28 |
| 2020 | 1 | 303 |
| 2021 | 0 | — |
| 2022 | 1 | 174 |
| 2023 | 1 | 155 |
| 2024 | 1 | 252 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neuwave Medical, Inc. took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | 10 | 10 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- Radiology (5)
Most recent Neuwave Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232227 | ABLATE-IQ | JAK | 2024-04-04 | 252 |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | NEY | 2023-11-16 | 155 |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | NEY | 2022-08-11 | 174 |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | NEY | 2020-11-13 | 303 |
| K192427 | Ablation Confirmation | JAK | 2019-10-03 | 28 |
| K173756 | Certus 140 2.45GHz Ablation System | NEY | 2018-10-24 | 317 |
| K171022 | Ablation Confirmation | JAK | 2017-05-09 | 34 |
| K163118 | FLEX Microwave Ablation System and Accessories | NEY | 2017-03-09 | 121 |
| K161285 | Ablation Confirmation | JAK | 2016-06-29 | 51 |
| K160936 | Certus 140 2.45GHz Ablation System | NEY | 2016-05-04 | 30 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neuwave Medical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neuwave Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Neuwave Medical, Inc.” (first 2010, latest 2024), across 3 product codes in 2 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 Neuwave Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neuwave Medical, Inc. is 149 days. Since 2017: 164 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neuwave Medical, Inc.?
The most frequent FDA product codes under this applicant name are NEY (System, Ablation, Microwave And Accessories, 10); JAK (System, X-Ray, Tomography, Computed, 4); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 15 Neuwave Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEY, Neuwave Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.