# K220107: Mindray SV600 Ventilator, Mindray SV800 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 16, 2023 after 520 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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: 3 generations back to K902859 (1991). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083050: Evite XL, Draeger Medical AG & Co. KG (2008) Summary page 4.
- K202405: BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K243767: SV600, SV800 Ventilator (2025), 0 descendants of its own

## Indications for use
The SV600, SV800 Ventilators are intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators 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/K220107
Methodology: https://510kreport.com/methodology