# K992702: Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System

- Pathway: 510(k) (Traditional)
- Applicant: Allergy Direct
- Decided: Nov 8, 1999 after 88 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
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. The FDA summary names its predicate without a number.
- (no number) ACb™ Elite: named in the summary without a submission number
- (no number) ACb™ Sheer: named in the summary without a submission number

## Indications for use
eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvet/comforters.

Source page: https://510kreport.com/device/K992702
Methodology: https://510kreport.com/methodology