# K112562: Bal Cath Bronchial Aspirate Sampling Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark
- Decided: Dec 15, 2011 after 80 days
- Product code: OYI (Non-Bronchoscopic Bronchoalveolar Lavage Catheter)
- 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 K923487 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923487: Bal Cath, Ballard Medical Products (1993) Summary page 1.

## Most influential descendants
- K150280: PulmoVia Working Channel (2015), 0 descendants of its own

## Indications for use
The Kimberly-Clark' KimVent' BAL CalM* Bronchial Aspirate Sampling Catheter is used in the diagnosis, of diffuse lung disease by allowing collection of bronchoalveolar lavage (GAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.

Source page: https://510kreport.com/device/K112562
Methodology: https://510kreport.com/methodology