Cleared Abbreviated

K110398 - RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS

K110398 is an FDA 510(k) clearance for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Abbreviated 510(k) pathway after a 110-day FDA review.

K110398 · Respironics, Inc. · Anesthesiology device
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Jun 2011
Decision
110d
Days
Class 2
Risk

K110398 is an FDA 510(k) clearance for the RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on June 1, 2011 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K110398

510(k) Number K110398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2011
Decision Date June 01, 2011
Days to Decision 110 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 140d · This submission: 110d
Pathway characteristics
Standards-based clearance path.

BZE Device Classification - Class 2, Special Controls

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
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 - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 22
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K110398.
RESPIRONICS REUSABLE HEATED TUBING
K140424 · Respironics, Inc. · Nov 2014
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · Fisher &Paykel Healthcare , Ltd. · Dec 2012
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · Fisher &Paykel Healthcare , Ltd. · Apr 2012
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · Fisher &Paykel Healthcare , Ltd. · Jan 2005
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · Allegiance Healthcare Corp. · Mar 2000
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999