F&P Nova Nasal Mask
FDA 510(k) K243583 · Fisher & Paykel Healthcare Limited
510(k) numberK243583
Submission
- Device name
- F&P Nova Nasal Mask
- Applicant
- Fisher & Paykel Healthcare Limited
Auckland, NZ - Received
- November 20, 2024
- Decision date
- June 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code BZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253553 | OrionBZD · Traditional | Resmed Corp | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…BZD · Traditional | Dcstar, Inc. | 05/21/2026SE |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | BMC Medical Co., Ltd. | 04/29/2026SE |
| K252338 | MySleepDashBZD · Traditional | Somnetics International, Inc. (Dba Transcend Inc) | 04/17/2026SE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
More from Resmed Corp
| 510(k) | Device | Decision |
|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | 12/19/2025SE |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…SGR · Traditional | 11/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | 09/10/2025SE |
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | 07/14/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | 06/25/2025SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | 08/09/2024SE |
| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | 08/09/2024SE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | 08/08/2024SE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J)BTT · Traditional | 06/13/2024SE |
| K222292 | F&P myAirvo 3BTT · Traditional | 05/08/2024SE |
Questions and answers
When was F&P Nova Nasal Mask cleared by the FDA?
F&P Nova Nasal Mask (K243583) received a 510(k) decision of Substantially Equivalent on June 18, 2025, 210 days after the submission was received.
What is the product code of K243583?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.