# K120931: Critical Care Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Oricare, Inc.
- Decided: Jun 6, 2013 after 436 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The V8800 Critical Care Ventilator is an electronically controlled, pneumatically powered machine intended to prov:de continuous ventilation to patients with respara!ory failure or resplratory msufF iciency, requmng resplratory support. The V8800 Critical Care Ventilator may be used by trained professional heatth care providers under the supervision of a physician. The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types .of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation. The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 |bs.) whose approximate age range is from birth to 1 month of age. The V8800 Critical Care Ventilator is intended for use in hospital and hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.

Source page: https://510kreport.com/device/K120931
Methodology: https://510kreport.com/methodology