510(k) Report

FDA applicant

Shenzhen Finicare Co., Ltd.

Shenzhen, CN6 decisions2019–20250 recalls

FDA records 6 decisions for Shenzhen Finicare Co., Ltd. (Shenzhen, CN) from 2019 to 2025: 6 510(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 134 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. 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 Finicare Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2019: 12022: 12023: 12024: 12025: 2
2019high 2 (2025) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Shenzhen Finicare Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
  • FLLContinuous Measurement Thermometer2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 134 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220113Upper Arm Electronic Blood Pressure Monitor (Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)Shenzhen Finicare Co., Ltd. · 20222cite it
  • K231367Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)Shenzhen Finicare Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)Shenzhen Finicare Co., Ltd. · 2025
  • K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)Shenzhen Finicare Co., Ltd. · 2025
  • K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130…Shenzhen Finicare Co., Ltd. · 2024
  • K231367Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)Shenzhen Finicare Co., Ltd. · 2023
  • K220113Upper Arm Electronic Blood Pressure Monitor (Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)Shenzhen Finicare Co., Ltd. · 2022
  • K181215Infrared ThermometerShenzhen Finicare Co., Ltd. · 2019

All 6 as Shenzhen Finicare Co., Ltd. →