Cleared Traditional

AirSpiral Heated Breathing Tube (K162553) - FDA 510(k) Clearance

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

K162553 · Fisher & Paykel Healthcare · Anesthesiology device
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Dec 2018
Decision
828d
Days
Class 2
Risk

K162553 is an FDA 510(k) clearance for the AirSpiral Heated Breathing Tube. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare (Auckland, NZ). The FDA issued a Cleared decision on December 20, 2018 after a review of 828 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K162553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2016
Decision Date December 20, 2018
Days to Decision 828 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
688d slower than avg
Panel avg: 140d · This submission: 828d
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 54
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K162553.
O2asis Personal Oxygen Humidifier
K193411 · Perma Pure, LLC · Nov 2020
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K191818 · Fisher &Paykel Healthcare , Ltd. · Mar 2020
Palladium High Flow Therapy System
K191010 · Vapotherm, Inc. · Oct 2019
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · Invacare Corp. · Mar 2004
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003