510(k) Report

FDA applicant

Shenzhen Yolanda Technology Co., Ltd.

Shenzhen, CN3 decisions2022–20230 recalls

FDA records 3 decisions for Shenzhen Yolanda Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2023: 3 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Shenzhen Yolanda Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 22023: 1
2022high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shenzhen Yolanda Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Yolanda Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report