Product code ONZ— Anesthesiology
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- Classification name
- Mechanical Ventilator
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Total cleared
- 6
- First cleared
- Most recent
FDA classification definition
“This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,”
Market context for product code ONZ
FDA has cleared devices under product code ONZ between 2009 and 2016, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2014
- 2011
- 2010
- 2009
Top applicants under product code ONZ
Recent clearances under product code ONZ
- K152664 — TAV System
- K131562 — BREATHE NIOV VENTILATION SYSTEM
- K103345 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- K102525 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- K100528 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
- K082982 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.