# K182821: Accutorr 7/VS-900/VS-900c Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 27, 2019 after 174 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K933143 (1994). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170712: Accutorr 7/VS-900 Vital Signs Monitor, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2017) Summary page 5.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 5.

## Recalls of this device
- Oct 1, 2019 · Class II · Z-0236-2020: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function

## Indications for use
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. • The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.

Source page: https://510kreport.com/device/K182821
Methodology: https://510kreport.com/methodology