1ST Response Reusable Manual Resuscitator (Adult)
510(k) K900577
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900577 | Date16 Jul 1990 | 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- Withdrawn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
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 1st Response Reusable Manual Resuscitator (Adult) is a manual emergency ventilator designed for resuscitation purposes. Classified as a Ventilator, Emergency, Manual (Resuscitator), it provides positive-pressure ventilation to patients who are not breathing or require respiratory support during cardiac arrest or other emergencies. Its primary function is to inflate the lungs of an unconscious or non-breathing adult patient by delivering controlled breaths via a bag-valve mechanism.
This reusable device is intended for use in pre-hospital, emergency department, and clinical settings where immediate respiratory assistance is required. Supplied as a reusable medical device, it must be cleaned, disinfected, and maintained according to manufacturer guidelines to ensure sterility and functionality between uses. The device is classified under FDA product code BTM and holds a Traditional 510(k) clearance (K900577) for substantial equivalence, adhering to regulatory standards for Class II medical devices. No MRI safety information or specific storage conditions are noted in the specifications.
Other devices from Intertech Resources, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the 1st Response Reusable Manual Resuscitator (Adult) used for?
This device is designed specifically for providing positive-pressure ventilation to adult patients who are not breathing or require respiratory support during emergencies such as cardiac arrest. It inflates the lungs via a bag-valve mechanism, ensuring immediate respiratory assistance in critical situations like pre-hospital care, emergency departments, or clinical settings.
How is the 1st Response Reusable Manual Resuscitator (Adult) supplied and prepared for use?
The device is supplied as a reusable medical instrument. After each use, it must be thoroughly cleaned, disinfected, and maintained according to the manufacturer’s guidelines to ensure sterility and proper functionality for subsequent uses. This process is essential to prevent cross-contamination and ensure reliable performance during emergencies.
Is the 1st Response Reusable Manual Resuscitator (Adult) single-use or reusable?
This device is explicitly designed for reuse. However, it requires rigorous cleaning, disinfection, and maintenance between uses to maintain sterility and operational integrity. The manufacturer provides specific protocols to ensure safe and effective reuse in clinical environments.
Are there specific storage requirements for the 1st Response Reusable Manual Resuscitator (Adult)?
The provided specifications do not include explicit storage conditions such as temperature or humidity requirements. However, it is generally recommended to store the device in a clean, dry environment, protected from physical damage and contamination, to preserve its functionality and sterility until the next use.
What regulatory pathway does the 1st Response Reusable Manual Resuscitator (Adult) follow?
The device holds a Traditional 510(k) clearance (K900577) from the FDA, demonstrating substantial equivalence to a predicate device. It is classified under FDA product code BTM and adheres to regulatory standards for Class II medical devices, ensuring compliance with safety and performance requirements for emergency ventilators.