# K221676: Exsalta

- Pathway: 510(k) (Traditional)
- Applicant: Drw Medical
- Decided: Sep 16, 2022 after 99 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K945062 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153663: Vario 8/18/ci, Medela AG (2016) Summary page 4.

## Indications for use
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient

Source page: https://510kreport.com/device/K221676
Methodology: https://510kreport.com/methodology