510(k) K260278
K260278 is an FDA 510(k) premarket notification submitted by Stihler Electronic GmbH for the device "ThermAffyx(TM) Patient Safety System". The FDA issued a decision of Substantially Equivalent on July 8, 2026. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Stihler Electronic GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2026
- Date Received
- January 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermal Regulating
- Device Class
- Class II
- Regulation Number
- 870.5900
- Review Panel
- CV
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).