DeviceClearance

SV70 Ventilator (SV70)— 510(k) K252182

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K252182 for SV70 Ventilator (SV70), Substantially Equivalent on 2026-04-06. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.

Summary

Shenzhen Mindray Bio-Medical Electronics' SV70 Ventilator is filed under product code MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator).

Class II, 21 CFR 868.5895. It came in as a Traditional 510(k), and Anesthesiology is both the classification panel and the review panel.

Shenzhen Mindray Bio-Medical Electronics filed from Shenzhen, China. Review took 269 calendar days (July 11, 2025 to April 6, 2026).

Clearance details

Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code
Product code MNT
Device class
Class 2
Regulation
21 CFR 868.5895
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 MNT

product code MNT
Death
118
Injury
324
Malfunction
25,451
Other
2
Total
25,895

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.