Cleared Traditional

AION TempShield?

K250401 · Aion Biosystems, Inc. · General Hospital

Mar 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250401 is an FDA 510(k) clearance for the AION TempShield?, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Aion Biosystems, Inc. (Lowell, US). The FDA issued a Cleared decision on March 14, 2025, 30 days after receiving the submission on February 12, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K250401 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2025
Decision Date	March 14, 2025
Days to Decision	30 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.