# K872621: Trach Care Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ballard Medical Products
- Decided: Sep 15, 1987 after 71 days
- Product code: BSY (Catheters, Suction, Tracheobronchial)
- Device class: 1
- Regulation: 21 CFR 868.6810
- Recalls of this device: 5 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955645: Cath-Guide (1996), 0 descendants of its own

## Recalls of this device
- Jun 13, 2003 · Not classified · Z-1081-03: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Jun 13, 2003 · Not classified · Z-1083-03: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Jun 13, 2003 · Not classified · Z-1079-03: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Jun 13, 2003 · Not classified · Z-1080-03: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Jun 13, 2003 · Not classified · Z-1082-03: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

Source page: https://510kreport.com/device/K872621
Methodology: https://510kreport.com/methodology