510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K211096Substantially Equivalent

Optiflow Oxygen Kit

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

K211096 is the FDA 510(k) clearance record for Optiflow Oxygen Kit, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K211096.

Clearance record

Decision date
Received
(290 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
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 BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260