510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250651Substantially Equivalent

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

Fisher & Paykel Healthcare, Inc., Auckland, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250651 is the FDA 510(k) clearance record for 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, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code SGR (Noninvasive Positive Airway Pressure System, Facility Use). FDA's definition for product code SGR reads: "To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure". FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K250651.

Clearance record

Decision date
Received
(260 days to decision)
Product code
SGR Noninvasive Positive Airway Pressure System, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Pl., E. Tamaki, Auckland, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGR

Trailing 12 months
2 clearances under product code SGR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260