Combibag Manual Resuscitator
510(k) K851171
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851171 | Date6 Sep 1985 | 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- Withdrawn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, 19 Sep 2026
The Combibag Manual Resuscitator is a manual emergency ventilator designed to deliver respiratory support during resuscitation. It operates via a bag-and-valve mechanism, providing ventilation through a face mask or airway tube, and is classified as a Class II device under FDA regulations. This device is intended for use in critical care settings where immediate respiratory assistance is required.
The Combibag Manual Resuscitator is supplied as a single-use device, intended for use in emergency medical scenarios. It is not MRI-compatible and must be stored in a clean, dry environment as per manufacturer guidelines. Authorized for use in the United States under FDA 510(k) clearance (K851171), it adheres to regulatory standards for emergency ventilators. No additional sterilization is required beyond standard pre-use preparation.
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Questions
AI-generated answers, 19 Sep 2026
What is the primary use case for the Combibag Manual Resuscitator in clinical settings?
The Combibag Manual Resuscitator is specifically designed for delivering emergency respiratory support during resuscitation. It uses a bag-and-valve mechanism to provide ventilation via a face mask or airway tube, making it ideal for critical care scenarios where immediate intervention is required, such as cardiac arrest or respiratory failure.
Is the Combibag Manual Resuscitator intended for repeated use, or is it a single-use device?
The Combibag Manual Resuscitator is explicitly labeled as a single-use device, meaning it is intended for one-time use in emergency medical scenarios. No additional sterilization is required beyond standard pre-use preparation, as it is pre-packaged for immediate deployment.
How should the Combibag Manual Resuscitator be stored to maintain its integrity?
The device must be stored in a clean, dry environment to preserve its functionality. Since it is single-use and pre-packaged, proper storage ensures it remains ready for emergency use without contamination or degradation. Avoid exposure to moisture, extreme temperatures, or direct sunlight.
What regulatory pathway was followed for FDA clearance of the Combibag Manual Resuscitator?
The Combibag Manual Resuscitator received FDA 510(k) clearance (K851171) under the Traditional 510(k) Review pathway, with a decision classification of *Substantially Equivalent* (SESE). The submission was reviewed by the Anesthesiology (AN) Advisory Committee and falls under the Product Code BTM, aligning with emergency manual resuscitators. This clearance confirms compliance with U.S. regulatory standards for Class II medical devices.
Are there any special handling requirements for the Combibag Manual Resuscitator, such as MRI compatibility or compatibility with specific airway devices?
The Combibag Manual Resuscitator is not MRI-compatible, meaning it should not be used in or near MRI environments. It is designed to work with face masks or airway tubes but does not specify compatibility with any particular brand or type. Always verify the airway interface compatibility with your facility’s standard equipment before use.