Inspiron(R) Breath for Life Emerg. Resuscitator
510(k) K870253
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870253 | Date6 Mar 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- Withdrawn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
- CBP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5870
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Inspiron Breath for Life Emergency Resuscitator is a valve, non-rebreathing device designed to assist in manual resuscitation by delivering oxygen or air to a patient’s lungs. It is intended for use in emergency situations where mechanical ventilation is unavailable or impractical, ensuring controlled ventilation during cardiopulmonary resuscitation (CPR).
This device is supplied as a reusable medical instrument and is classified under FDA regulation 868.5870 as a Class II device, with an FDA 510(k) clearance (K870253) granted in 1987. It is intended for use in clinical settings such as emergency rooms, pre-hospital care, and anesthesia suites, where rapid and reliable ventilation support is required. The device is not MRI-compatible and must be stored in a clean, dry environment to maintain functionality.