# K950192: Skytron Skyboom Series

- Pathway: 510(k) (Traditional)
- Applicant: Skytron, Div. the Kmw Group, Inc.
- Decided: Apr 3, 1995 after 75 days
- Product code: FQO (Table, Operating-Room, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4960
- Recalls of this device: 4 (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 5, 2020 · Class II · Z-1569-2020: Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
- Mar 28, 2016 · Class II · Z-1871-2016: Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
- Aug 4, 2005 · Not classified · Z-1496-06: The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.
- Aug 4, 2005 · Not classified · Z-1497-06: The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.

Source page: https://510kreport.com/device/K950192
Methodology: https://510kreport.com/methodology