Cleared Special

K251611 - Optiflow+ Nasal Cannula - Small (OPT942)

Also marketed or referenced as:
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)

K251611 is an FDA 510(k) clearance for Optiflow+ Nasal Cannula - Small (OPT942), manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Special 510(k) pathway after a 29-day FDA review.

K251611 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
29d
Days
Class 2
Risk

K251611 is an FDA 510(k) clearance for the Optiflow+ Nasal Cannula - Small (OPT942). 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 June 25, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K251611

510(k) Number K251611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2025
Decision Date June 25, 2025
Days to Decision 29 days
Submission Type Special
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
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

BTT Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K251611.
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K251611 · Optiflow+ Nasal Cannula - Small (OPT942)
Download PDF FDA Summary Fisher &Paykel Health…