# K944729: Stylet Sheath with Locking Cap and Reusable Battery Operated Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Coast Medical, Inc.
- Decided: Dec 21, 1994 after 86 days
- Product code: BSR (Stylet, Tracheal Tube)
- Device class: 1
- Regulation: 21 CFR 868.5790
- 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 13, 2015 · Class II · Z-1556-2015: Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that ma
- Mar 13, 2015 · Class II · Z-1557-2015: Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that ma
- Aug 11, 2008 · Not classified · Z-2454-2008: Light protector may detach from lighted stylet during intubation.
- Aug 11, 2008 · Not classified · Z-2455-2008: Light protector may detach from lighted stylet during intubation.
- Aug 11, 2008 · Not classified · Z-2456-2008: Light protector may detach from lighted stylet during intubation.

Source page: https://510kreport.com/device/K944729
Methodology: https://510kreport.com/methodology