Data / Medical devices / United States / Aion Biosystems
Aion Biosystems: FDA-registered device maker in Lowell, MA, United States, 2 510(k) clearances
Aion Biosystems is registered with the FDA (registration 3028019184) in Lowell, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028019184
- Address
- 175 Cabot Street Suite 100, Lowell, MA, United States, 01854
- Owner or operator
- AION Biosystems (10088613)
- Roles
- Specification developer
- First device listed
- August 31, 2023
- Registered through
- 2026
- Brand names listed
- AION TempShield, iTempShield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | 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 |
|---|---|---|---|---|---|---|
| March 14, 2025 | K250401 | AION TempShield | FLL | Substantially Equivalent | Aion Biosystems, Inc. | accessdata.fda.gov |
| August 4, 2023 | K232010 | iTEMPSHIELD | FLL | Substantially Equivalent | Aion Biosystems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 14, 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.