Manual Disposable Pulmonary Resuscitator
by F.L.W. Plastics, Inc. 510(k)
Active
510(k) K895169
Overview
A Manual Disposable Pulmonary Resuscitator is a ventilator, emergency, manual (resuscitator) device used to provide manual ventilation to patients in emergency situations. It is classified as a Class II medical device and has been determined to be substantially equivalent to a legally marketed device.
The device is supplied as a single-use, non-sterile product intended for use in emergency and clinical settings. It is not MRI safe and is authorized under FDA 510(k) clearance K895169 with product code BTM and regulation number 868.5915.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895169 | Date13 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- Withdrawn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 F.L.W. Plastics, Inc.
Questions
What is the Manual Disposable Pulmonary Resuscitator used for?
The Manual Disposable Pulmonary Resuscitator is a ventilator device used to provide manual ventilation to patients in emergency situations. It is designed for use in both emergency and clinical settings where manual ventilation is required.
Is the device sterile and can it be reused?
The device is supplied as a single-use, non-sterile product, meaning it is not intended to be resterilized or reused after use. Each unit should be discarded after a single patient use to ensure safety and prevent cross-contamination.
What are the regulatory approvals for this device?
The Manual Disposable Pulmonary Resuscitator is classified as a Class II medical device and has FDA 510(k) clearance K895169 with product code BTM and regulation number 868.5915. It has been determined to be substantially equivalent to legally marketed devices.
Is the device safe for use in MRI environments?
No, the Manual Disposable Pulmonary Resuscitator is not MRI safe. It should not be used in MRI environments as it may pose safety risks due to its materials or design not being compatible with the strong magnetic fields present in MRI scanners.