# K091250: Diagnostic Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: May 22, 2009 after 24 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923487 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974642: Combicath Catheter, Plastimed Laboratoire Pharmaceutique (1998) Summary page 1.
- K923487: Bal Cath, Ballard Medical Products (1993) Summary page 1.

## Indications for use
The Diagnostic Catheter System is intended for use as a sampling device by performing mini-bronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.

Source page: https://510kreport.com/device/K091250
Methodology: https://510kreport.com/methodology