# K171827: ReddyPort NIV Access Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Smd Manufacturing, LLC
- Decided: Jan 19, 2018 after 213 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231064: ReddyPort Elbow (2023), 0 descendants of its own

## Indications for use
The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K171827
Methodology: https://510kreport.com/methodology