# K964369: Trach Care Set with Microban

- Pathway: 510(k) (Traditional)
- Applicant: Ballard Medical Products
- Decided: Feb 11, 1997 after 102 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031997: Mallinckrodt Dar TY-Care / TY-Care Exel Closed  Suction System (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K964369
Methodology: https://510kreport.com/methodology