Data / Medical devices / United States / Huxley Medical
Huxley Medical: FDA-registered device maker in Atlanta, GA, United States, 4 510(k) clearances
Huxley Medical is registered with the FDA (registration 3032906215) in Atlanta, GA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 10, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3032906215
- Address
- 1465 Northside Dr Nw Ste 217, Atlanta, GA, United States, 30318
- Owner or operator
- Huxley Medical (10091588)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 17, 2024
- Registered through
- 2027
- Brand names listed
- SANSA, SANSA HSAT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2025 | K252497 | SANSA HSAT | MNR | Substantially Equivalent | Huxley Medical | accessdata.fda.gov |
| October 29, 2025 | K250882 | SANSA HSAT | MNR | Substantially Equivalent | Huxley Medical | accessdata.fda.gov |
| January 28, 2025 | K244027 | SANSA HSAT | MNR | Substantially Equivalent | Huxley Medical | accessdata.fda.gov |
| July 15, 2024 | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | MNR | Substantially Equivalent | Huxley Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Breathing Frequency
- All makers of Ventilatory Effort Recorder
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated December 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.