# K043234: Light Drape

- Pathway: 510(k) (Traditional)
- Applicant: Wrapped IN Comfort
- Decided: May 25, 2005 after 184 days
- Product code: MMP (Cover, Barrier, Protective)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093618: Bili-Mirror Model BLM-1 (2010), 0 descendants of its own

## Indications for use
Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Source page: https://510kreport.com/device/K043234
Methodology: https://510kreport.com/methodology