Jet Ventilator
by Healthdyne, Inc. 510(k)
Active
510(k) K813254
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813254 | Date4 Feb 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Jet Ventilator is a continuous-use medical device designed to provide mechanical ventilation by delivering high-pressure gas jets to the patient’s airway, facilitating lung inflation. It operates as an alternative to conventional positive-pressure ventilators, leveraging compressed gas to drive airflow without relying on a piston or diaphragm mechanism. This design is particularly suited for controlled environments where precise respiratory support is required, such as in anesthesia or critical care settings.
This device is intended for facility use and has received FDA clearance under 510(k) classification (K813254) as a Class II medical device, regulated under 21 CFR 868.5895. It is not described as single-use or reusable in the submitted data, though its operational context—typically in operating rooms or intensive care units—implies routine cleaning and maintenance. No MRI safety information or specific size variations are provided in the regulatory records. The device’s authorization reflects its submission to the FDA’s Anesthesiology Device Panel for review.