Cleared Traditional

iTEMPSHIELD

K232010 · Aion Biosystems, Inc. · General Hospital

Aug 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K232010 is an FDA 510(k) clearance for the iTEMPSHIELD, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Aion Biosystems, Inc. (Darien, US). The FDA issued a Cleared decision on August 4, 2023, 29 days after receiving the submission on July 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K232010 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2023
Decision Date	August 04, 2023
Days to Decision	29 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.