# K982945: Dual Purpose Closed Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Spirit Medical Systems, Inc.
- Decided: Sep 22, 1998 after 32 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
Longest line of descent: 1 generation back to K833375 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833375: Dual Purpose Catheter, Jinotti Ent Inc. Medical (1984) Summary page 1.

## Indications for use
The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient’s trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

Source page: https://510kreport.com/device/K982945
Methodology: https://510kreport.com/methodology