# K915285: Skytron Infinity Series Surgical Lights

- Pathway: 510(k) (Traditional)
- Applicant: Skytron, Div. the Kmw Group, Inc.
- Decided: Feb 20, 1992 after 87 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 11 (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
- Jan 8, 2007 · Not classified · Z-0524-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0530-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0533-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0526-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0534-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0525-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0527-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0528-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0529-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0531-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Jan 8, 2007 · Not classified · Z-0532-2007: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.

Source page: https://510kreport.com/device/K915285
Methodology: https://510kreport.com/methodology