DeviceClearance

A5 Anesthesia System (A5); A7 Anesthesia System (A7)— 510(k) K253330

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K253330 for A5 Anesthesia System (A5); A7 Anesthesia System (A7), Substantially Equivalent on 2026-06-25. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.

Summary

Shenzhen Mindray Bio-Medical Electronics' clearance covers two anesthesia systems, the A5 and the A7. They're filed under BSZ, anesthesia gas machines, and the record doesn't say how the two differ.

Class II, 21 CFR 868.5160. Anesthesiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Mindray filed from Shenzhen, China. Review took 268 calendar days (September 30, 2025 to June 25, 2026).

Clearance details

Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code
Product code BSZ
Device class
Class 2
Regulation
21 CFR 868.5160
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BSZ

product code BSZ
Death
23
Injury
298
Malfunction
32,987
Total
33,308

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.