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FDA 510(k)

AION TempShield™

K-Number: K250401 · 2025-03-14

ApplicantAion Biosystems, Inc.
Decision Date2025-03-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AION TempShield™ is the device name listed in this FDA 510(k) record. The listed applicant is Aion Biosystems, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K250401. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AION TempShield™?

AION TempShield™ is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Aion Biosystems, Inc.. The 510(k) number is K250401.

When did AION TempShield™ receive FDA 510(k) clearance?

AION TempShield™ received FDA 510(k) clearance on 2025-03-14, under 510(k) number K250401.

Who is the listed applicant for AION TempShield™?

The FDA 510(k) record lists Aion Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AION TempShield™?

The FDA product code for AION TempShield™ is FLL.

Other records listing Aion Biosystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232010iTEMPSHIELD

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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