# K152884: DermaTherapy Bed Linens

- Pathway: 510(k) (Traditional)
- Applicant: Precision Fabrics Group, Inc.
- Decided: Jun 20, 2016 after 264 days
- Product code: FMW (Cover, Mattress (Medical Purposes))
- Device class: 1
- Regulation: 21 CFR 880.6190
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903382 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061242: Dermatherapy, Model 22216, Precision Fabrics Group, Inc. (2007) Summary page 4.

## Indications for use
Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin.

Source page: https://510kreport.com/device/K152884
Methodology: https://510kreport.com/methodology