Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)— 510(k) K251160

Substantially Equivalent

Shenzhen Med-Link Electronics Tech Co., Ltd.

FDA 510(k) clearance K251160 for Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), Substantially Equivalent on 2026-01-08. Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd..

Clearance details

Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2025-04-15
Decision date: 2026-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.