Phasor Health, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Phasor Health, LLC” (first 2025, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 122 days, against 129 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 |
|---|---|---|
| 2025 | 5 | 122 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Phasor Health, LLC took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
Review panels
- Neurology (5)
Most recent Phasor Health, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252696 | LEGACY | HBG | 2025-11-21 | 86 |
| K252514 | EVAC-MRI | JXG | 2025-11-05 | 86 |
| K252060 | GREEN | HBE | 2025-10-31 | 122 |
| K250505 | EZ-FIDUCIALS | HAW | 2025-07-09 | 138 |
| K243205 | EVAC | JXG | 2025-06-03 | 245 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-03-21.
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 Phasor Health, LLC?
FDA lists 5 510(k) clearances under the applicant name “Phasor Health, LLC” (first 2025, latest 2025), across 4 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 Phasor Health, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phasor Health, LLC is 122 days. Since 2017: 122 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Phasor Health, LLC?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 2); HAW (Neurological Stereotaxic Instrument, 1); HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 1).
Next steps
- See all 5 Phasor Health, LLC clearances with predicates and recalls
- Run predicate analysis for product code JXG, Phasor Health, LLC'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.