HistoSonics, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “HistoSonics, Inc.” (first 2024, latest 2026), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 141 days. Since 2017 the median was 141 days, against 249 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 |
|---|---|---|
| 2024 | 2 | 131 |
| 2025 | 0 | — |
| 2026 | 1 | 256 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name HistoSonics, Inc. took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 249 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QGM | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation | 3 | 2 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 1 | 1 |
Review panels
Most recent HistoSonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252947 | HistoSonics® Planning Tool | QTZ | 2026-05-29 | 256 |
| K241902 | Edison System | QGM | 2024-10-30 | 121 |
| K233466 | Edison System | QGM | 2024-03-13 | 141 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220087 | De Novo | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation | 2023-10-06 |
Recalls
openFDA lists no recalls under a recalling firm named HistoSonics, 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.
Device clinical trials
An industry sponsor named HistoSonics, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT07214675: The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy (Recruiting, started 2026-03-20)
- NCT06282809: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy (Recruiting, started 2024-12-10)
- NCT06486454: Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) (Recruiting, started 2024-10-14)
- NCT05820087: The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY) (Active not recruiting, started 2024-01-04)
- NCT05432232: The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy (Completed, started 2023-03-23)
Frequently asked questions
How many FDA 510(k) clearances are listed under HistoSonics, Inc.?
FDA lists 3 510(k) clearances under the applicant name “HistoSonics, Inc.” (first 2024, latest 2026), plus 1 De Novo decision, across 2 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 HistoSonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name HistoSonics, Inc. is 141 days. Since 2017: 141 days, versus 249 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under HistoSonics, Inc.?
The most frequent FDA product codes under this applicant name are QGM (Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation, 3); QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, 1).
Next steps
- See all 3 HistoSonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QGM, HistoSonics, 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.