RT016 Inspiratory Filter
by Fisher & Paykel Healthcare, Inc.
510(k) K133666
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133666 | Date5 Feb 2014 | 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- Withdrawn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
- FDA applicant
- Fisher & Paykel Healthcare, Ltd.
- 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
The RT016 Inspiratory Filter is a Filter, Bacterial, Breathing-Circuit designed to remove microbiological and particulate matter from inhaled gases in a breathing circuit. It is classified as a Class II device under FDA regulations (21 CFR 868.5260) and is intended for use in respiratory support systems, including mechanical ventilation circuits. The filter operates within the breathing circuit to enhance patient safety by reducing contamination risks during inhalation phases.
This single-use, non-sterile device is supplied as part of a breathing circuit system and is regulated under the FDA’s 510(k) clearance (K133666). It is intended for use in anesthesia and respiratory care settings, adhering to standards for bacterial filtration in breathing circuits. The filter is not MRI-compatible and must be handled in accordance with manufacturer guidelines to ensure proper function and patient safety. No additional sterilization is required prior to use.
Other devices from Fisher & Paykel Healthcare, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the RT016 Inspiratory Filter designed for?
The RT016 Inspiratory Filter is specifically designed to remove microbiological and particulate matter from inhaled gases within a breathing circuit. It enhances patient safety by reducing contamination risks during the inhalation phase, making it ideal for use in respiratory support systems, including mechanical ventilation circuits. This is particularly important in anesthesia and respiratory care settings where maintaining a sterile environment is critical.
Is the RT016 Inspiratory Filter sterile and how is it supplied?
The RT016 Inspiratory Filter is supplied as a non-sterile device and is intended for single-use only. It is part of a breathing circuit system and does not require additional sterilization before use. Always follow manufacturer guidelines to ensure proper handling and functionality.
Can the RT016 Inspiratory Filter be reused?
No, the RT016 Inspiratory Filter is designed for single-use only. Reusing it could compromise its effectiveness in filtering bacteria and particulate matter, potentially increasing contamination risks for the patient. Always use a new filter for each procedure to maintain safety and performance.
Is the RT016 Inspiratory Filter compatible with MRI machines?
No, the RT016 Inspiratory Filter is not MRI-compatible. If MRI imaging is required for a patient using this device, it must be removed from the breathing circuit beforehand. Always check manufacturer guidelines to ensure proper use and safety in all clinical environments.
What regulatory approval does the RT016 Inspiratory Filter hold?
The RT016 Inspiratory Filter is classified as a Class II device under FDA regulations (21 CFR 868.5260) and has received FDA 510(k) clearance (K133666). This clearance confirms that the device meets FDA standards for safety and effectiveness as a bacterial filter in breathing circuits. Always refer to the manufacturer’s documentation for the most up-to-date regulatory information.