Pilairo Nasal Pillows Mask
by Fisher & Paykel Healthcare, Inc.
510(k) K120027
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120027 | Date23 Feb 2012 | 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- Withdrawn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
- BZD
- FDA applicant
- Fisher & Paykel Healthcare Limited
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Pilairo Nasal Pillows Mask is a nasal pillows continuous positive airway pressure (CPAP) mask designed to deliver respiratory support by directing airflow directly into the nasal passages. It features two nasal prongs that fit within the nostrils, providing minimal facial coverage and reducing the risk of claustrophobia for some users.
This device is supplied as a single-use or reusable system, depending on the components, and is intended for use in clinical settings such as operating rooms or recovery areas under the supervision of anesthesiology personnel. It has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device. The mask is available in a single size, with two headgear options for improved fit and comfort.
Other devices from Fisher & Paykel Healthcare, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Pilairo Nasal Pillows Mask designed for, and who typically supervises its use?
The Pilairo Nasal Pillows Mask is specifically designed for use in controlled clinical environments like operating rooms or recovery areas. It is intended to be used under the direct supervision of anesthesiology personnel, ensuring proper administration of respiratory support during procedures.
Can the Pilairo Nasal Pillows Mask be reused, or is it meant for single-use only?
The Pilairo Nasal Pillows Mask is available as either a single-use or reusable system, depending on the specific components selected. This flexibility allows healthcare providers to choose based on facility protocols, infection control needs, and cost considerations.
How many sizes or headgear options are available for the Pilairo Nasal Pillows Mask, and why might this matter?
The mask is available in a single size but includes two headgear options to improve fit and comfort for different patient anatomies. This design helps minimize air leaks and reduces the risk of discomfort or pressure points during prolonged use.
Is the Pilairo Nasal Pillows Mask intended for general respiratory support, or is it specialized for a particular procedure?
While the mask delivers continuous positive airway pressure (CPAP) for respiratory support, its primary regulatory filing route is under the Anesthesiology advisory committee, indicating it is optimized for use in perioperative settings (e.g., during surgeries or recovery) rather than general respiratory therapy.
How was the FDA clearance for this device determined, and what does that mean for its regulatory status?
The Pilairo Nasal Pillows Mask received FDA clearance under the Traditional 510(k) pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. This classification confirms it meets FDA safety and effectiveness standards for its intended use as a nasal pillows CPAP mask in clinical anesthesia settings.