# K981910: Suction Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ni-Med, Inc.
- Decided: Aug 24, 1998 after 84 days
- Product code: BSY (Catheters, Suction, Tracheobronchial)
- Device class: 1
- Regulation: 21 CFR 868.6810
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the NI-MED suction catheter kit is for the physician to asplrate liquids or semi-solids from a patient's upper airway.

Source page: https://510kreport.com/device/K981910
Methodology: https://510kreport.com/methodology