PPG Biomedical Ventilator Model AV 400
510(k) K871433
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871433 | Date29 May 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 1 Oct 2026
The PPG Biomedical Ventilator Model AV 400 is a continuous-use ventilator designed for facility-based respiratory support. It delivers controlled mechanical ventilation to patients requiring assisted or full respiratory support, maintaining oxygenation and ventilation in clinical settings such as operating rooms, intensive care units, and recovery areas. This device is classified as a Class II medical device under FDA regulations, adhering to standards for patient safety and performance in critical care environments.
The ventilator is intended for facility use and is supplied as a reusable device, requiring proper maintenance and sterilization protocols as outlined by the manufacturer. It operates within specific regulatory parameters, including FDA clearance under 510(k) number K871433, and is intended for continuous use in controlled medical environments. The device’s design and specifications align with regulatory requirements for ventilators, ensuring compliance with safety and performance standards for respiratory support systems.
Other devices from Ppg Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PPG AV 400 ventilator used for?
The PPG AV 400 is a facility-use ventilator intended for delivering controlled mechanical ventilation to patients requiring assisted or full respiratory support. It is specifically designed for clinical settings such as operating rooms, intensive care units (ICUs), and recovery areas, ensuring oxygenation and ventilation during critical care procedures.
Is the PPG AV 400 ventilator reusable or single-use?
The PPG AV 400 ventilator is a reusable device. As such, it requires proper maintenance and sterilization protocols as outlined by the manufacturer to ensure safety and functionality for repeated use in clinical environments.
What regulatory approval does the PPG AV 400 ventilator hold?
The PPG AV 400 ventilator holds FDA clearance under the 510(k) pathway, specifically with clearance number K871433. This clearance confirms that the device meets regulatory standards for safety and performance as a Class II medical device.
How is the PPG AV 400 ventilator supplied?
The PPG AV 400 ventilator is supplied as a reusable device, meaning it is intended for use across multiple patients in a facility setting. It must be maintained and sterilized according to manufacturer guidelines to ensure reliability and infection control.
What types of clinical environments is the PPG AV 400 ventilator intended for?
The PPG AV 400 ventilator is designed for facility-based use in controlled medical environments where continuous respiratory support is required. This includes operating rooms, intensive care units (ICUs), and recovery areas, where precise ventilation control is essential for patient care.