F&P 950 Respiratory Humidifier
by Fisher & Paykel Healthcare, Inc.
510(k) K220703
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220703 | Date16 Jun 2023 | 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- Withdrawn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
- BTT
- FDA applicant
- Fisher & Paykel Healthcare
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5450
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The F&P 950 Respiratory Humidifier is a Respiratory Gas Humidifier (Direct Patient Interface), designed to condition respiratory gases by adding precise heat and humidity. It ensures optimal moisture levels in inhaled gases, reducing the risk of airway irritation and improving patient comfort during ventilation or inhalation therapy. This device is classified as a Class II medical device under FDA regulations.
The F&P 950 is intended for use in clinical settings such as operating rooms, intensive care units, and anesthesia environments. It is supplied as a reusable device and requires sterile water for operation, adhering to USP standards. The system is MRI-safe and available in configurations compatible with various respiratory circuits and patient interfaces. Authorized under FDA 510(k) clearance (K220703), it is regulated under 21 CFR 868.5450 for respiratory therapy devices.
Other devices from Fisher & Paykel Healthcare, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical environments is the F&P 950 Respiratory Humidifier designed for use in?
The F&P 950 Respiratory Humidifier is specifically designed for use in high-precision respiratory care settings such as operating rooms, intensive care units (ICUs), and anesthesia environments. Its purpose is to condition respiratory gases by adding precise heat and humidity, ensuring optimal moisture levels for patients undergoing ventilation or inhalation therapy.
Is the F&P 950 Respiratory Humidifier reusable, and what type of water does it require for operation?
Yes, the F&P 950 is a reusable device. It requires sterile water for operation, adhering to USP (United States Pharmacopeia) standards to maintain hygiene and safety in clinical settings.
Can the F&P 950 Respiratory Humidifier be used with MRI equipment, and what respiratory circuits does it support?
Yes, the F&P 950 is MRI-safe, meaning it can be used in environments with MRI equipment without interference. It is also designed to be compatible with various respiratory circuits and patient interfaces, making it versatile for different clinical needs.
How is the regulatory status of the F&P 950 Respiratory Humidifier determined, and what does this mean for its use?
The F&P 950 is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance (K220703), which means it has been determined to be substantially equivalent to a legally marketed device. This clearance ensures it meets FDA standards for safety and effectiveness, allowing it to be legally marketed and used in clinical settings as described.
What types of configurations or models are available for the F&P 950 Respiratory Humidifier?
The F&P 950 is available in multiple configurations, as indicated by the extensive list of FEI numbers in the regulatory data. These configurations are designed to be compatible with various respiratory circuits and patient interfaces, ensuring flexibility for different clinical applications and patient needs.