Cleared Traditional

K171827 - ReddyPort NIV Access Elbow (FDA 510(k) Clearance)

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

K171827 · Smd Manufacturing, LLC · Anesthesiology device
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Jan 2018
Decision
213d
Days
Class 2
Risk

K171827 is an FDA 510(k) clearance for the ReddyPort NIV Access Elbow. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Smd Manufacturing, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 213 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Smd Manufacturing, LLC devices

Submission Details

510(k) Number K171827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2017
Decision Date January 19, 2018
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 139d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

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