# K233486: 731 Series Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Dec 13, 2024 after 413 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K902859 (1991). 130 ancestors in all.
No later device cites it as a predicate yet.
14 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162832: 731 Series Ventilators, ZOLL Medical Corporation (2017) Summary page 5.

## Indications for use
Ventilation Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. Pulse Oximetry (Sp02) The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02), and pulse rate. The pulse Sp02 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

Source page: https://510kreport.com/device/K233486
Methodology: https://510kreport.com/methodology