Cleared Traditional

K160540 - FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

K160540 is an FDA 510(k) clearance for FLEXICARE NEONATAL HEATED WIRE BREATHIN..., manufactured by Flexicare Medical Limited.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K160540 · Flexicare Medical Limited. · Anesthesiology device
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Jun 2016
Decision
118d
Days
Class 2
Risk

K160540 is an FDA 510(k) clearance for the FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM. 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 Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on June 23, 2016 after a review of 118 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 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.

View all Flexicare Medical Limited. devices

FDA 510(k) Submission Details - K160540

510(k) Number K160540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date June 23, 2016
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K160540.
Neonatal ConchaSmart Breathing Circuits
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AirLife Adult Heated Wire Circuit
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Hybernite RT
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AirLife Infant Heated Wire Circuit
K151303 · Care Fusion · Jan 2016
AirLife Infant Single Limb Heated Wire Circuit
K151959 · Carefusion, Inc. · Jan 2016