Cleared Special

K000697 - MODIFICATION TO AIRLIFE HEATED VENTILAT...

K000697 is an FDA 510(k) clearance for MODIFICATION TO AIRLIFE HEATED VENTILAT..., manufactured by Allegiance Healthcare Corp.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Special 510(k) pathway after a 29-day FDA review.

K000697 · Allegiance Healthcare Corp. · Anesthesiology device
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Mar 2000
Decision
29d
Days
Class 2
Risk

K000697 is an FDA 510(k) clearance for the MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING 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 Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on March 30, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - 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. 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 Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K000697

510(k) Number K000697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2000
Decision Date March 30, 2000
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.

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 K000697.
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · Fisher &Paykel Healthcare , Ltd. · Apr 2012
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · Respironics, Inc. · Jun 2011
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · Fisher &Paykel Healthcare , Ltd. · Jan 2005
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · Marquest Medical Products, Inc. · Jan 1997
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993