# K011549: Ohmeda Medical Spot PT Lite Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jul 19, 2001 after 62 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K170585: Skylife (2017), 0 descendants of its own
- K120820: Giraffe Blue Spot PT Lite (2012), 0 descendants of its own

## Recalls of this device
- Nov 18, 2016 · Class II · Z-1503-2017: Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fi

Source page: https://510kreport.com/device/K011549
Methodology: https://510kreport.com/methodology