# K190630: SolidAIRity III Airway Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Securisyn Medical, LLC
- Decided: Oct 9, 2019 after 211 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: 4 generations back to K961837 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
4 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111401: Bever Endotracheal Tube, Bever Eva Endotracheal Tube, Hangzhou Bever Medical Devices Co., Ltd. (2012) Summary page 4.
- K843790: Tracheal Tube Fixation Device, Laerdal California, Inc. (1985) Summary page 4.

## Indications for use
The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation. The SolidAIRity III Endotracheal Suction Tube is indicated for airway management of patients requiring oral intubation and for evacuation and drainage of subglottic secretions that accumulate above the cuff. The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.

Source page: https://510kreport.com/device/K190630
Methodology: https://510kreport.com/methodology