Breathing Circuit Bacterial/Viral Filter
by Shaoxing Haitech Medical Products Co., Ltd. 510(k)
Active
510(k) K222917
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222917 | Date15 Feb 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 19 Sep 2026
This device is a Filter, Bacterial, Breathing-Circuit, classified under FDA product code CAH. It is designed to remove microbiological and particulate contaminants from gases within the breathing circuit, ensuring cleaner air delivery during anesthesia or respiratory support procedures.
The filter is intended for single-use in clinical settings, including operating rooms and anesthesia workstations. It is regulated under FDA 510(k) clearance (K222917) as a Class 2 device, adhering to the Substantially Equivalent standard for traditional pathway review. No additional sterility or MRI safety information is specified in the regulatory data.
Other devices from Shaoxing Haitech Medical Products Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is this breathing circuit filter intended for, and how is it used?
This bacterial/viral filter is designed for single-use in clinical environments where respiratory support or anesthesia is provided, such as operating rooms and anesthesia workstations. It is placed within the breathing circuit to remove microbiological and particulate contaminants from gases, ensuring cleaner air delivery during procedures.
Is this filter reusable, or is it meant for one-time use only?
The filter is explicitly intended for single-use only, meaning it should not be reused after a single clinical procedure. This design ensures optimal performance and sterility for patient safety.
What sizes or models of this breathing circuit filter are available?
The provided data lists multiple registration numbers (e.g., 3009896423, 3013242701) associated with this device, which likely correspond to different sizes or configurations. While exact dimensions or model names aren’t specified, these identifiers suggest variability in sizing to accommodate different breathing circuit systems. For precise sizing details, refer to the manufacturer’s packaging or technical documentation.
How should this filter be stored before use?
The data does not specify storage conditions, but as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Check the manufacturer’s instructions for any additional storage guidelines, such as expiration dates or protective packaging requirements.
What regulatory pathway was followed for FDA clearance, and how does that affect its use?
This device was cleared via the FDA 510(k) pathway (K222917) under the *Substantially Equivalent* standard for a traditional review, classified as a Class 2 device. The clearance was reviewed by the Anesthesiology Device Advisory Panel, confirming its safety and effectiveness for removing microbiological contaminants in breathing circuits. The regulatory route ensures compliance with FDA standards for bacterial filters in anesthesia/respiratory settings, but it does not imply additional features like sterility guarantees or MRI safety.