# K132037: Vital Signs Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Mindray North America
- Decided: May 16, 2014 after 319 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933143 (1994). 45 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K202892: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (2021), 1 descendant of its own
- K233038: Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (2024), 0 descendants of its own
- K221113: Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor (2022), 0 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-0235-2020: 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
- Oct 1, 2019 · Class II · Z-0238-2020: 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 monitor Is intended for spot-check monitoring physiologic parameters, including 8p02, PR, NISP and TEMP, on adult, pediatric, and neonatal patients Inhealthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K132037
Methodology: https://510kreport.com/methodology