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SV70 Ventilator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252182

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Identifiers

510(k) Number
K252182 FDA 510(k)
FDA Product Code
MNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SV70 Ventilator is a non-invasive mechanical ventilator designed for adult and pediatric patients. It provides six ventilation modes—CPAP, S, S/T, P-A/C, VAPS, and PPV—as well as oxygen therapy, supporting respiratory management in clinical settings.

This device is intended for hospital use and features a 15.6-inch touchscreen interface with EasySync™ technology for enhanced patient synchrony. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The ventilator is not described as single-use or reusable in the provided data.

Frequently asked questions

What ventilation modes does the SV70 Ventilator support, and how might they benefit patients in clinical settings?

The SV70 Ventilator supports six ventilation modes: CPAP (Continuous Positive Airway Pressure), S (Spontaneous), S/T (Spontaneous/Time), P-A/C (Pressure-Assisted Control), VAPS (Volume-Assisted Pressure Support), and PPV (Pressure-Presure Ventilation). These modes provide flexibility for managing both adult and pediatric patients, allowing clinicians to tailor respiratory support to specific patient needs, such as spontaneous breathing assistance, controlled ventilation, or oxygen therapy.

Is the SV70 Ventilator designed for single-use or can it be reused in a hospital setting?

The provided data does not explicitly state whether the SV70 Ventilator is single-use or reusable. However, given its hospital-use classification and the absence of any mention of disposable components, it is likely intended for reuse with proper cleaning and maintenance protocols. Always follow manufacturer guidelines and institutional policies for device reprocessing.

What type of interface does the SV70 Ventilator feature, and how does it enhance patient care?

The SV70 Ventilator includes a 15.6-inch touchscreen interface with EasySync™ technology, which improves patient synchrony during ventilation. This design allows clinicians to easily adjust settings and monitor patient data in real-time, reducing the risk of asynchrony and improving overall respiratory management.

What regulatory pathways has the SV70 Ventilator undergone, and which advisory committee was involved?

The SV70 Ventilator has received FDA 510(k) clearance and MDD authorization, indicating it is classified as a Class II medical device under FDA regulations. The device was reviewed by the Anesthesiology (AN) Advisory Committee during its submission process, as noted in the advisory committee description.

How is the SV70 Ventilator supplied, and are there multiple models or configurations available?

The provided data lists multiple registration numbers (e.g., 3011120183, 3007573469) under the product code MNT, which may correspond to different configurations or models of the SV70 Ventilator. While the exact specifications of these models are not detailed, this suggests there could be variations in features or capabilities. For precise details on supply or model differences, refer to the manufacturer’s documentation or contact Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SV70/SV70S - Ventilator - Mindray, SV70 Ventilator - mindray.com, SV70/SV70S - Mindray

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K252182 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026