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FDA 510(k)

ThermAffyx(TM) Patient Safety System

K-Number: K260278 · 2026-07-08

ApplicantStihler Electronic GmbH
Decision Date2026-07-08
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ThermAffyx(TM) Patient Safety System is the device name listed in this FDA 510(k) record. The listed applicant is Stihler Electronic GmbH. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K260278. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermAffyx(TM) Patient Safety System?

ThermAffyx(TM) Patient Safety System is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is Stihler Electronic GmbH. The 510(k) number is K260278.

When did ThermAffyx(TM) Patient Safety System receive FDA 510(k) clearance?

ThermAffyx(TM) Patient Safety System received FDA 510(k) clearance on 2026-07-08, under 510(k) number K260278.

Who is the listed applicant for ThermAffyx(TM) Patient Safety System?

The FDA 510(k) record lists Stihler Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermAffyx(TM) Patient Safety System?

The FDA product code for ThermAffyx(TM) Patient Safety System is DWJ.

Other records listing Stihler Electronic GmbH 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.

K202197Astopad Patient Warming System

Related Devices (Code: DWJ)

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.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health TechnologiesK243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.

Official Source

View on FDA Database →

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

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