Cleared Traditional

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 11
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K160540.
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
K222822 · Draegerwerk AG & CO Kgaa · Jun 2023
Sunset Heated CPAP Tube
K201418 · Sunset Healthcare Solutions, Inc. · Jan 2021
Neonatal ConchaSmart Breathing Circuits
K173280 · Teleflexmedical, Inc. · Aug 2018
RESPIRONICS REUSABLE HEATED TUBING
K140424 · Respironics, Inc. · Nov 2014
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · Respironics, Inc. · Jun 2011
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993