Cleared Traditional

F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) (K191818) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191818 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Mar 2020
Decision
258d
Days
Class 2
Risk

K191818 is an FDA 510(k) clearance for the F&P Optiflow 3S Nasal Cannula (Small, Medium, Large). Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on March 19, 2020 after a review of 258 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K191818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2019
Decision Date March 19, 2020
Days to Decision 258 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 139d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 50
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K191818.
HVT 2.0
K203357 · Vapotherm, Inc. · Aug 2021
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
K201723 · Fisher &Paykel Healthcare , Ltd. · Mar 2021
O2asis Personal Oxygen Humidifier
K193411 · Perma Pure, LLC · Nov 2020
Palladium High Flow Therapy System
K191010 · Vapotherm, Inc. · Oct 2019
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018