iTEMPSHIELD: FDA 510(k) K232010, Aion Biosystems, Inc.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK232010	Date4 Aug 2023Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K232010

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K232010
FDA product code: FLL

Device class: Class II
Regulation: 21 CFR Part 880.2910
Advisory committee: General Hospital
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Radius T wearable thermometer K203215 11 Jun 2021 FDA record · FDA summary

Cited by

AION TempShield™ K250401 14 Mar 2025 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K232010

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232010
		UDI-DI	Size and differences
TempShield DWF-1824 Aion Biosystems, Inc.	DWF-1824	00197644811199	—	On the market

Similar devices

Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).

Other devices from Aion Biosystems, Inc.

TempShield DWF-1824

Class II
AION TempShield

Class II