# K243767: SV600, SV800 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Aug 28, 2025 after 265 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: 14 generations back to K902859 (1991). 71 ancestors in all.
No later device cites it as a predicate yet.
5 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220107: Mindray SV600 Ventilator, Mindray SV800 Ventilator, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2023) Summary page 5.
- K213799: N Series Patient Monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2022) Summary page 5.
- K083050: Evite XL, Draeger Medical AG & Co. KG (2008) Summary page 5.
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1, Maquet Critical Care AB (2019) Summary page 5.

## Indications for use
The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 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/K243767
Methodology: https://510kreport.com/methodology