# K213098: Panther 5

- Pathway: 510(k) (Traditional)
- Applicant: Origin Medical Devices
- Decided: Jul 20, 2023 after 664 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Panther 5 is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonates with Very Low Birth Weight (VLBW) <1500 gm to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospital type facilities and during hospital and hospital-type transport provided that electrical power and compressed Oxygen are supplied.

Source page: https://510kreport.com/device/K213098
Methodology: https://510kreport.com/methodology