510(k) Report

FDA applicant

Shenzhen Realtone Medical Appliance Co., Ltd.

Shenzhen, CN1 decision2021–20210 recalls

FDA records 1 decision for Shenzhen Realtone Medical Appliance Co., Ltd. (Shenzhen, CN) in 2021: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). Its devices cite 1 predicate, 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, general and plastic surgery panel, where it files most

How often FDA has decided Shenzhen Realtone Medical Appliance Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Shenzhen Realtone Medical Appliance Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K210878Surgical Face Mask (Model: CM2006, CM2008, A88)Shenzhen Realtone Medical Appliance Co., Ltd. · 2021

The one decision as Shenzhen Realtone Medical Appliance Co., Ltd. →