ThermAffyx(TM) Patient Safety System— 510(k) K260278

Name: FDA 510(k) clearance K260278
Creator: U.S. Food and Drug Administration
Published: 2026-07-08

Substantially Equivalent

Stihler Electronic GmbH

FDA 510(k) clearance K260278 for ThermAffyx(TM) Patient Safety System, Substantially Equivalent on 2026-07-08. Applicant: Stihler Electronic GmbH. Device class: 2.

Clearance details

Applicant: Stihler Electronic GmbH
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2026-01-29
Decision date: 2026-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leinfelden-Echterdingen, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.