Bacteria Filter
by Foregger Air Products & Chem., Inc.
510(k) K760567
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760567 | Date15 Sep 1976 | 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- Withdrawn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
- CAH
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5260
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Filter, Bacterial, Breathing-Circuit, classified as a Class II medical device under 21 CFR 868.5260. It is designed to remove microbiological and particulate contaminants from gases within a breathing circuit, ensuring cleaner air delivery during respiratory support or anesthesia procedures. The filter operates as a critical barrier in closed-loop systems to prevent microbial cross-contamination between patients and equipment.
The Bacteria Filter is intended for single-use in clinical settings such as operating rooms, intensive care units, or anesthesia delivery systems. Supplied sterile and packaged for immediate use, it is regulated under FDA 510(k) clearance (K760567) and falls under the CAH product code. No reusable or MRI-compatible variants are specified; compliance with sterility and filtration efficacy is ensured through regulatory submission to the Anesthesiology Advisory Committee. Sizes or additional technical specifications are not detailed in the provided data.
Other devices from Foregger Air Products & Chem., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Foregger Bacteria Filter designed for?
The Foregger Bacteria Filter is specifically designed to remove microbiological and particulate contaminants from gases within breathing circuits. This ensures cleaner air delivery during respiratory support or anesthesia procedures, acting as a critical barrier to prevent microbial cross-contamination between patients and equipment in closed-loop systems.
How is the Bacteria Filter supplied and intended for use?
The filter is supplied sterile and packaged for immediate single-use in clinical settings such as operating rooms, intensive care units, or anesthesia delivery systems. It is not intended for reuse or reusable applications, ensuring patient safety through its sterile design and single-use nature.
Is the Bacteria Filter compatible with MRI equipment?
The provided data does not specify MRI compatibility for the Foregger Bacteria Filter. Clinicians should verify compatibility with their specific MRI systems before use, as no MRI-compatible variants are mentioned in the documentation.
What regulatory pathway does the Bacteria Filter follow?
The Foregger Bacteria Filter is regulated under the FDA 510(k) clearance pathway, with the clearance number K760567. It was reviewed by the Anesthesiology Advisory Committee and classified as a Class II medical device under 21 CFR 868.5260, ensuring compliance with stringent regulatory standards for filtration efficacy and sterility.
Are there different sizes or models available for the Bacteria Filter?
The provided data does not detail specific sizes or additional technical specifications for the Bacteria Filter. However, multiple registration numbers suggest various models or variants may exist, though no explicit size or model differentiation is described in the available information.