Dryden Mini Bacteria Filter
by Dryden Corp. 510(k)
Active
510(k) K840205
Overview
The Dryden Mini Bacteria Filter is a breathing-circuit bacterial filter. It is designed to function as a component within an anesthesia breathing circuit to filter bacteria.
This device is regulated under 21 CFR 868.5260 and is classified as a Class 2 medical device. It has received FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840205 | Date4 Feb 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Dryden Corp.
Questions
What is the primary purpose of the Dryden Mini Bacteria Filter?
This device is designed to function as a component within an anesthesia breathing circuit to filter bacteria, helping to maintain the integrity of the circuit during clinical use.
How is this device regulated?
The Dryden Mini Bacteria Filter is regulated under 21 CFR 868.5260 and is classified as a Class 2 medical device. It has received FDA 510(k) clearance under the number K840205.
What is the medical specialty associated with this filter?
This device is categorized under the Anesthesiology medical specialty, as it is specifically engineered for use within anesthesia breathing circuits.