AION TempShield
510(k) K250401
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250401 | Date14 Mar 2025 | StatusActive |
Official records
- FDA 510(k) database K250401
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLL
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
AION TempShield is a continuous temperature monitoring wearable device. It is designed for use in general hospital settings as a substantially equivalent device under FDA 510(k) clearance.
The device is supplied as a wearable monitor and is authorized under FDA 510(k) with K number K250401 and product code FLL. It is intended for use in the United States and is manufactured by Aion Biosystems, Inc. in Lowell, MA.
Similar devices
Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).
- Infrared Forehead Thermometer IR-FT by Comper Chuangxiang (Beijing) Technology Co., Ltd.
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- Infrared Thermometer IR8807 by Shen Zhen Rong Feng Technology Co., Ltd.
- Up-Grade Forehead Thermometer by Medisim, Ltd.
- BD Flexible Digital Thermometer by Bd Becton Dickinson Vacutainer Systems Preanalytic
- VALEO VT-601 SERIES IR THERMOMETER by Valeo Corp.
- Duteck Digital Clinical Thermometer by Duteck Industrial Co., Ltd.
- Abreu Model 700 by Brain Tunnelgenix Technologies Corp
- IVAC 819 Electronic Thermometer by Y