Cleared Traditional

K171827 - ReddyPort NIV Access Elbow

K171827 is an FDA 510(k) clearance for ReddyPort NIV Access Elbow, manufactured by Smd Manufacturing, LLC. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 213-day FDA review.

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

FDA 510(k) Submission Details - K171827

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNS Device Classification - Class 2, Special Controls

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

All 35
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K171827.
Vivo 1, Vivo 2
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Juno VPAP ST-A
K161492 · Resmed, Ltd. · Jan 2017
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487 · Resmed, Ltd. · Sep 2016
Juno VPAP ST-A
K153061 · Resmed, Ltd. · Apr 2016