# K063055: VS-800 Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 21, 2006 after 77 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K933143 (1994). 40 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400, Critikon Company, LLC (2000) Summary page 2.
- K060281: VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.
- K043348: Modification to PM-8000 Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2005) Summary page 4.

## Most influential descendants
- K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor (2007), 7 descendants of its own
- K132037: Vital Signs Monitor (2014), 3 descendants of its own
- K132038: Accutorr 7 Vital Signs Monitor (2014), 2 descendants of its own
- K100740: MD2000B Vital Sign Monitor, Model MD2000B (2010), 2 descendants of its own
- K202892: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (2021), 1 descendant of its own

## Indications for use
The VS-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.

Source page: https://510kreport.com/device/K063055
Methodology: https://510kreport.com/methodology