Negative Pressure Chest Respirator Pump
by J. H. Emerson Co. 510(k)
Active
510(k) K832176
Overview
This device is a Ventilator, External Body, Negative Pressure, Adult (Cuirass), classified under FDA regulation 868.5935. It functions as an external negative pressure ventilator, designed to support patient ventilation by applying controlled negative pressure via a chamber, such as a cuirass, to assist breathing. The device is intended for use in anesthesiology settings and operates by creating a sealed environment around the patient’s torso to facilitate respiratory mechanics. Its design relies on alternating cycles of negative pressure to expand the lungs and aid ventilation in adult patients.
The Negative Pressure Chest Respirator Pump is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K832176), with a decision of Substantially Equivalent (SESE) issued in 1983. It falls under Class II device classification and is intended for use in clinical environments where external negative pressure ventilation is required. The device’s specifications align with the product code BYT and regulatory requirements for external body ventilators. No sterility or single-use designation is indicated in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832176 | Date12 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BYT
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5935
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the Negative Pressure Chest Respirator Pump used for?
The Negative Pressure Chest Respirator Pump is an external negative pressure ventilator intended to support adult patients' ventilation in clinical settings, particularly in anesthesiology. It works by creating a sealed environment around the patient’s torso using a cuirass chamber, then applying controlled cycles of negative pressure to expand the lungs and aid respiratory mechanics.
Is the Negative Pressure Chest Respirator Pump a single-use or reusable device?
The Negative Pressure Chest Respirator Pump is designed as a reusable medical device. It is not designated for single-use, allowing for repeated use in clinical environments after proper cleaning and maintenance.
What regulatory approval does the Negative Pressure Chest Respirator Pump hold?
The device holds FDA 510(k) clearance under the reference number K832176, with a decision of Substantially Equivalent (SESE) issued in 1983. It is classified as a Class II device and is regulated under FDA regulation 868.5935, with the product code BYT.
In what clinical settings is this device primarily intended for use?
This device is primarily intended for use in anesthesiology settings where external negative pressure ventilation is required. It is designed to assist patients who need respiratory support outside of traditional positive-pressure ventilation methods.
How is the Negative Pressure Chest Respirator Pump supplied?
The device is supplied as a reusable medical device, meaning it is intended for multiple uses in clinical environments. It requires proper cleaning, maintenance, and sterilization procedures between uses to ensure safety and functionality.