510(k) Report

FDA applicant

Shenzhen Pango Medical Electronics Co., Ltd.

Shenzhen, CN3 decisions2022–20240 recalls

FDA records 3 decisions for Shenzhen Pango Medical Electronics Co., Ltd. (Shenzhen, CN) from 2022 to 2024: 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 231 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 Pango Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12023: 12024: 1
2022high 1 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • FLLContinuous Measurement Thermometer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 231 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K223291Electronic Blood Pressure MonitorShenzhen Pango Medical Electronics Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47…Shenzhen Pango Medical Electronics Co., Ltd. · 2024
  • K223291Electronic Blood Pressure MonitorShenzhen Pango Medical Electronics Co., Ltd. · 2023
  • K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd. · 2022

All 3 as Shenzhen Pango Medical Electronics Co., Ltd. →