LIFE-02 Non-Refillable Cylinder
by Life Corp.
510(k) K910699
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910699 | Date18 Jun 1991 | 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- Withdrawn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
- BTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5925
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Life-02 is an emergency powered ventilator and resuscitator. It is designed to provide respiratory support during emergency situations.
This device is a non-refillable cylinder supplied for medical use. It has received FDA 510k clearance.
Other devices from Life Corporation
Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the LIFE-02?
The LIFE-02 is designed to serve as an emergency powered ventilator and resuscitator. It is intended to provide respiratory support to patients during emergency situations.
Is the LIFE-02 cylinder refillable?
No, the LIFE-02 is a non-refillable cylinder. It is supplied as a single-use unit for medical respiratory support applications.
Has the LIFE-02 received regulatory authorization?
Yes, the LIFE-02 has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the anesthesiology medical specialty.