# K761190: Tracheostomy Care Kit

- Pathway: 510(k) (Traditional)
- Applicant: Superior Plastic Products Corp.
- Decided: Dec 16, 1976 after 10 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Dec 4, 2023 · Class I · Z-1044-2024: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Source page: https://510kreport.com/device/K761190
Methodology: https://510kreport.com/methodology