ThermAffyx(TM) Patient Safety System— 510(k) K260278
Substantially EquivalentStihler 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.
Summary
Stihler Electronic's ThermAffyx Patient Safety System is filed under DWJ, thermal regulating systems. The record doesn't list the system's components.
Class II, 21 CFR 870.5900. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Stihler Electronic filed from Leinfelden-Echterdingen, Germany. Review took 160 calendar days (January 29 to July 8, 2026).
Clearance details
- Applicant
- Stihler Electronic GmbH
- Product code
- Product code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leinfelden-Echterdingen, DE
Recent devices under product code DWJ
view allMore clearances from Stihler Electronic GmbH
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . 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.