# K902180: Tracheal Tube Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Sims Surgical, Inc.
- Decided: Jul 19, 1990 after 65 days
- Product code: BSR (Stylet, Tracheal Tube)
- Device class: 1
- Regulation: 21 CFR 868.5790
- Recalls of this device: 3 (0 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.
0 of 1 device 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.

## Recalls of this device
- May 19, 2004 · Not classified · Z-1016-04: Incompatible products may cause potential trachea trauma
- May 19, 2004 · Not classified · Z-1017-04: Incompatible products may cause potential trachea trauma
- Jan 26, 2004 · Not classified · Z-0572-04: Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr

Source page: https://510kreport.com/device/K902180
Methodology: https://510kreport.com/methodology