Cleared Traditional

K151303 - AirLife Infant Heated Wire Circuit

K151303 is an FDA 510(k) clearance for AirLife Infant Heated Wire Circuit, manufactured by Care Fusion. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K151303 · Care Fusion · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
248d
Days
Class 2
Risk

K151303 is an FDA 510(k) clearance for the AirLife Infant Heated Wire 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 Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 248 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K151303

510(k) Number K151303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date January 21, 2016
Days to Decision 248 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
108d slower than avg
Panel avg: 140d · This submission: 248d
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 34
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K151303.
AirLife Adult Heated Wire Circuit
K153234 · Carefusion, Inc. · Jul 2016
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
K160540 · Flexicare Medical Limited. · Jun 2016
Hybernite RT
K151461 · Plastiflex Group NV · Mar 2016
AirLife Infant Single Limb Heated Wire Circuit
K151959 · Carefusion, Inc. · Jan 2016
Flexicare Heated Wire Breathing Systems
K150900 · Flexicare Medical, Ltd. · May 2015
RESPIRONICS REUSABLE HEATED TUBING
K140424 · Respironics, Inc. · Nov 2014