Single Patient Use Disposable Manual Resuscitator
by Puritan Bennett Corp. 510(k)
Active
510(k) K894365
Overview
The Single Patient Use Disposable Manual Resuscitator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory assistance. It is designed for manual ventilation in emergency situations where mechanical ventilation is not available.
This device is supplied as a single-patient use disposable product and is classified as a Class II medical device under product code BTM with special controls. It is not indicated for MRI use and should be stored according to the manufacturer's instructions. The device received FDA 510(k) clearance on October 6, 1989, under K894365.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894365 | Date6 Oct 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the intended use of the Single Patient Use Disposable Manual Resuscitator?
The device is intended to provide emergency respiratory assistance through manual ventilation in situations where mechanical ventilation is not available, as it incorporates a bag and valve system designed for this purpose.
How is the Single Patient Use Disposable Manual Resuscitator supplied and intended for use?
It is supplied as a single-patient use disposable product, meaning it is designed for one-time use on a single patient and should not be reused or reprocessed after initial use.
What regulatory pathway was used for the clearance of this device, and when was it cleared?
The device received FDA 510(k) clearance on October 6, 1989, under submission number K894365, following a traditional review process and was found substantially equivalent to a predicate device.
Is the Single Patient Use Disposable Manual Resuscitator safe to use in an MRI environment?
No, the device is not indicated for MRI use, as explicitly stated in the device data, and should not be brought into or used within an MRI suite due to potential safety risks.
What are the storage requirements for the Single Patient Use Disposable Manual Resuscitator?
The device should be stored according to the manufacturer's instructions, as specified in the device data, to maintain its integrity and functionality prior to use in emergency situations.