Cleared Special

K993833 - AIRLIFE HEATED VENTILATOR AND BREATHING...

K993833 is an FDA 510(k) clearance for AIRLIFE HEATED VENTILATOR AND BREATHING..., 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 28-day FDA review.

K993833 · Allegiance Healthcare Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
28d
Days
Class 2
Risk

K993833 is an FDA 510(k) clearance for the AIRLIFE HEATED VENTILATOR AND 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 December 10, 1999 after a review of 28 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 - K993833

510(k) Number K993833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 10, 1999
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 K993833.
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
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · Allegiance Healthcare Corp. · Mar 2000
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
FLEXHTR-1
K894654 · Bird Products Corp. · Aug 1990