Cleared Traditional

K173384 - BLUselect

K173384 is an FDA 510(k) clearance for BLUselect, manufactured by Smiths Medical Ads, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K173384 · Smiths Medical Ads, Inc. · Anesthesiology device
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Apr 2018
Decision
162d
Days
Class 2
Risk

K173384 is an FDA 510(k) clearance for the BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fene.... Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Smiths Medical Ads, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 10, 2018 after a review of 162 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Smiths Medical Ads, Inc. devices

FDA 510(k) Submission Details - K173384

510(k) Number K173384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2017
Decision Date April 10, 2018
Days to Decision 162 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
22d slower than avg
Panel avg: 140d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 47
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