Reflexion Medical, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Reflexion Medical, Inc.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 251 days. 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 |
|---|---|---|
| 2020 | 1 | 332 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 170 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reflexion Medical, Inc. took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QVA | Fludeoxyglucose F18-Guided Radiation Therapy System | 2 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
Review panels
- Radiology (3)
Most recent Reflexion Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | QVA | 2025-12-18 | 170 |
| K190978 | RefleXion Medical Radiotherapy System | IYE | 2020-03-12 | 332 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220014 | De Novo | Fludeoxyglucose F18-Guided Radiation Therapy System | 2023-02-01 |
Recalls
4 product recalls in 4 recall events; 4 initiated in the last five years. Most recent: 2026-02-09.
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 Reflexion Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05406167: Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System (Recruiting, started 2022-04-12)
- NCT04788147: Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X) (Completed, started 2021-03-26)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Reflexion Medical, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Reflexion Health, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reflexion Medical, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Reflexion Medical, Inc.” (first 2020, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reflexion Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reflexion Medical, Inc. is 251 days.
Which FDA product codes appear under Reflexion Medical, Inc.?
The most frequent FDA product codes under this applicant name are QVA (Fludeoxyglucose F18-Guided Radiation Therapy System, 2); IYE (Accelerator, Linear, Medical, 1).
Next steps
- See all 2 Reflexion Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QVA, Reflexion 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.