Cleared Traditional

K173280 - Neonatal ConchaSmart Breathing Circuits

K173280 is the FDA 510(k) clearance for Neonatal ConchaSmart Breathing Circuits by Teleflexmedical, Inc.. It is a Class 2 Anesthesiology device (product code BZE) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K173280 · Teleflexmedical, Inc. · Anesthesiology device
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Aug 2018
Decision
290d
Days
Class 2
Risk

K173280 is an FDA 510(k) clearance for the Neonatal ConchaSmart 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 Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 2, 2018 after a review of 290 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.

View all Teleflexmedical, Inc. devices

Submission Details

510(k) Number K173280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2017
Decision Date August 02, 2018
Days to Decision 290 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
150d slower than avg
Panel avg: 140d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 18
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K173280.
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