510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171827Substantially Equivalent

ReddyPort NIV Access Elbow

SMD Manufacturing LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K171827 is the FDA 510(k) clearance record for ReddyPort NIV Access Elbow, a class II device, cleared for Smd Manufacturing, LLC on under FDA product code MNS (Ventilator, Continuous, Non-Life-Supporting). FDA records list 2 510(k) clearances for Smd Manufacturing, LLC, from to . As of , FDA records show no recalls naming K171827.

Clearance record

Decision date
Received
(213 days to decision)
Product code
MNS Ventilator, Continuous, Non-Life-Supporting
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Smd Manufacturing, LLC 2500 S State St. Suite D224, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code MNS

Trailing 12 months
3 clearances under product code MNS in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260