# K001003: Z-NET

- Pathway: 510(k) (Traditional)
- Applicant: Demite Limited
- Decided: Dec 10, 2001 after 621 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: 1 generation back to K903382 (1990). 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)
- K903382: Allergy Control Covers, Allergy Control Products, Inc. (1990) Summary page 1.
- (no number) Other mattress covers classified under 21 CFR § 880.6190: named in the summary without a submission number

## Indications for use
Z-Net reduces for up to 15 months house dust mites and their allergens in bedding, a leading cause of allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers.

Source page: https://510kreport.com/device/K001003
Methodology: https://510kreport.com/methodology