# K252182: SV70 Ventilator (SV70)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 6, 2026 after 269 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K833786 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082660: V60 Ventilator, Model V8000, Respironics California, Inc. (2009) Summary page 5.
- K213521: Nihon Kohden NKV-330 Ventilator System, Nihon Kohden Orangemed, Inc. (2022) Summary page 5.

## Indications for use
The SV70 Ventilator is intended for use in a professional healthcare facility or during transport in a professional healthcare facility. The SV70 Ventilator is intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 20 kg, who are spontaneously breathing individuals with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The SV70 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

Source page: https://510kreport.com/device/K252182
Methodology: https://510kreport.com/methodology