# K221113: Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 2, 2022 after 231 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: 10 generations back to K933143 (1994). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132037: Vital Signs Monitor, Mindray North America (2014) Summary page 5.

## Indications for use
The Accutorr 3/Rosebud Vital Signs monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP) and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K221113
Methodology: https://510kreport.com/methodology