# K111401: Bever Endotracheal Tube, Bever Eva Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Bever Medical Devices Co., Ltd.
- Decided: Jul 19, 2012 after 427 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: 3 generations back to K961837 (1996). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
4 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 1.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 1.

## Most influential descendants
- K151381: Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (2015), 3 descendants of its own
- K223130: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) (2023), 2 descendants of its own
- K233341: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (2024), 1 descendant of its own
- K250173: Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) (2025), 0 descendants of its own
- K190630: SolidAIRity III Airway Stabilization System (2019), 0 descendants of its own

## Indications for use
The BEVERm Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during mechanical ventilation and anesthesia. BEVER Evam Endotracheal Tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the contaminated mucous and subglottic secretion that accumulate above the cuff by continuous or intermittent suctioning.

Source page: https://510kreport.com/device/K111401
Methodology: https://510kreport.com/methodology