# K083702: Trach-Assist

- Pathway: 510(k) (Traditional)
- Applicant: Mergenet Medical
- Decided: Mar 5, 2009 after 80 days
- Product code: BZA (Connector, Airway (Extension))
- Device class: 1
- Regulation: 21 CFR 868.5810
- 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 K770771 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850964: Double-Swivel Connector, Sheridan Catheter Corp. (1985) Summary page 1.
- K833373: Bodia Bronch-Saf Double Swivel, Sontek Industries, Inc. (1983) Summary page 1.
- K770771: Aerosol Effusion System #1740, Hudson Oxygen Therapy Sales Co. (1977) Summary page 1.
- K063125: Filterflo Hepa; Thermoflo Hepa (Filter / Hme), Arc Medical, Inc. (2007) Summary page 1.

## Indications for use
The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.

Source page: https://510kreport.com/device/K083702
Methodology: https://510kreport.com/methodology