510(k) Report

FDA applicant

Shenzhen Viatom Technology Co., Ltd.

Shenzhen, CN5 decisions2019–20250 recalls

FDA records 5 decisions for Shenzhen Viatom Technology Co., Ltd. (Shenzhen, CN) from 2019 to 2025: 5 510(k) clearances. Most are in product codes DQA (Oximeter) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 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 Viatom Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 22020: 12022: 12025: 1
2019high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Shenzhen Viatom 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.

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Which product codes does it file in?

  • DQAOximeter3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 205 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 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 20192cite it

What has FDA decided for it lately?

  • K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd. · 2025
  • K203812Oxyfit Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2022
  • K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd. · 2020
  • K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019
  • K190207Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd. · 2019

All 5 as Shenzhen Viatom Technology Co., Ltd. →