# K013116: Durq/ Qualidura

- Pathway: 510(k) (Traditional)
- Applicant: Ever-Safety Technical Service
- Decided: Jan 18, 2002 after 122 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
It is designed to improve the disadvantages of the conventional rubber bulb type aspirators with poor suction power, unstable and hard to use. Now no more squeezing by hands or suction by mouth. It removes nasal mucus and fluids from baby’s nostrils at home safely and easily.

Source page: https://510kreport.com/device/K013116
Methodology: https://510kreport.com/methodology