# K141747: Rhinoguard

- Pathway: 510(k) (Traditional)
- Applicant: Davis Medical
- Decided: Apr 20, 2015 after 294 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931165 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931164: Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EY, Rusch, Inc. (1993) Summary page 5.
- K931165: Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur Eye, Rusch, Inc. (1993) Summary page 5.

## Indications for use
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx. The device can be used with cuffed and non-cuffed nasal endotracheal tubes.

Source page: https://510kreport.com/device/K141747
Methodology: https://510kreport.com/methodology