510(k) Report

FDA applicant

Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.

Shenzhen, Guang Dong, CN1 decision2015–20150 recalls

FDA records 1 decision for Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. (Shenzhen, Guang Dong, CN) in 2015: 1 510(k) clearance. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 2 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, anesthesiology panel, where it files most

How often FDA has decided Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd. · 2015

The one decision as Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. →