Breathing Circuit Bacterial Filters
510(k) K892520
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892520 | Date2 Aug 1989 | 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- Withdrawn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, 19 Sep 2026
A breathing circuit bacterial filter is a Class II medical device designed to remove microbiological and particulate contaminants from gases within the breathing circuit during anesthesia or respiratory support. It functions as a barrier to prevent cross-contamination between patients, breathing systems, and the clinical environment, ensuring sterile airflow in critical care settings.
These filters are intended for single-use in anesthesia and respiratory care settings. They are supplied sterile and must be discarded after use to maintain infection control. Compliance with FDA 510(k) clearance (K892520) and regulatory standards (868.5260) ensures their safety and performance. Multiple reference codes (e.g., 3009896423, 1832562) identify authorized variants, all adhering to the same design controls and bacterial filtration requirements.