# K201876: Soteria Bed Barrier

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Guardion
- Decided: Sep 1, 2022 after 786 days
- Product code: QTV (Mattress And Bed Deck Cover (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: 1 generation back to K780033 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780033: Mattresses, Conductive & Covers, Chase Mfg. Co. (1978) Summary page 4.

## Indications for use
The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use. The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Source page: https://510kreport.com/device/K201876
Methodology: https://510kreport.com/methodology