# K123144: VIVO 50

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare, Breas Medical AB
- Decided: Jun 18, 2013 after 256 days
- Product code: NOU (Continuous, Ventilator, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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: 10 generations back to K902859 (1991). 83 ancestors in all.
8 later devices descend from it; 1 cites it directly.
11 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112754: IVENT101, Versamed Medical Systems, Ltd. (2012) Summary page 2.
- K111610: Trilogy Series Ventilator with Oximetry, Respironics, Inc. (2011) Summary page 2.
- K081601: Veo Multigas Monitor for Pocket PC, Phasein AB (2008) Summary page 2.
- K123043: Irma C02 Model 200101; Irma AX 200601, Phasein AB (2012). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K160481: Vivo 60 (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-2094-2015: Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be regis

## Indications for use
The Vivo 50 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for: pediatric through adult patients weighing at least 10 kg (22 Ibs.l The Vivo 50 with the iOxy is intended to measure functional oxygen soturotlon of arterial hemoglobin (%Sp02) and pulse rate. The Vivo 50 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gos. The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 50 is not intended to be used as a transport and critical care ventilator.

Source page: https://510kreport.com/device/K123144
Methodology: https://510kreport.com/methodology