FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
K Number: K250651
·
Decision Nov 19, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
70
Review Days
260
Basic Information
- Device Name
- OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
- K Number
- K250651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Date Received
- March 4, 2025
- Decision Date
- November 19, 2025
- Product Code
- SGR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SGR), ordered by most recent decision date.
View allOther Clearances by Fisher & Paykel Healthcare, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Dec 19, 2025 | Substantially Equivalent |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Sep 10, 2025 | Substantially Equivalent |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Jul 14, 2025 | Substantially Equivalent |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Jun 25, 2025 | Substantially Equivalent |
| K234053 | F&P Optiflow Flow Diverter | Aug 9, 2024 | Substantially Equivalent |
| K233643 | F&P Airvo 3 NIV (PT311US) | Aug 9, 2024 | Substantially Equivalent |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Aug 8, 2024 | Substantially Equivalent |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Jun 13, 2024 | Substantially Equivalent |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Feb 7, 2024 | Substantially Equivalent |
| K223684 | F&P 820 Humidification System | Sep 5, 2023 | Substantially Equivalent |