Cleared Traditional

K915226 - ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT

K915226 is an FDA 510(k) clearance for ISOTHERMAL HEATED VENTILATOR & ANESTHES..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K915226 · Baxter Healthcare Corp · Anesthesiology device
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Jan 1993
Decision
419d
Days
Class 2
Risk

K915226 is an FDA 510(k) clearance for the ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT. 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 Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on January 12, 1993 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K915226

510(k) Number K915226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1991
Decision Date January 12, 1993
Days to Decision 419 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
279d slower than avg
Panel avg: 140d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K915226.
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999
CRITERION, CRITERION I.V., MODIFIED
K952267 · Nova-Ventrx · Dec 1997
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · Marquest Medical Products, Inc. · Jan 1997
FLEXHTR-1
K894654 · Bird Products Corp. · Aug 1990
BREATHING CIRCUIT W/HEATED WIRE
K880769 · Dryden Corp. · Aug 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · Intertech Resources, Inc. · Jul 1988