510(k) Report

510(k) · Cleared

Cleared

Z-NET

K001003510(k) TraditionalCleared Dec 10, 2001621-day reviewClass I21 CFR 880.6190

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Demite Limited · FMW Cover, Mattress (Medical Purposes)

Cleared on Dec 10, 2001 as substantially equivalent to K903382 (Allergy Control Products, Inc., 1990) after a 621-day review. Its family tree reaches back 1 generation to 1990.

Decided
Dec 10, 2001
Review
621 days
Class
Class I
Product code
FMW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K903382 (1990). No later device cites it as a predicate yet.

K903382 · Allergy Control Covers · Allergy Control Products, Inc. · 19901990199219941996199820002002
K903382 · Allergy Control Covers · Allergy Control Products, Inc. · 19900
  1. Root · 1 generation backK903382 Allergy Control CoversAllergy Control Products, Inc. · 1990
  2. This deviceK001003 Z-NETDemite Limited · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903382Allergy Control CoversAllergy Control Products, Inc.1990—
0 (this device)K001003Z-NETDemite Limited2001—
FIG. 1 — Lineage of K001003, 1990–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K903382Allergy Control Covers
Summary page 1
…lergy control mattress and pillow covers e Classification Name: Mattress cover for medical purposes (per 21 CFR § 880.6150) o Predicate Device: Allergy Control Covers (K903382) and other mattress covers classified under 21 CFR § 880.6190. C. Device Description The Z-Net allergy control device consists…
Allergy Control Products, Inc.1990—
*—Other mattress covers classified under 21 CFR § 880.6190
Named without a submission number
—

Also cleared against K903382: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K903382.

How does its category compare?

All FMW devices

FMW Cover, Mattress (Medical Purposes): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMW

1in 2016

2007: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMW

Too few FMW 510(k)s in any year since 2007 to give a median.

Recalls per year · FMW

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FMW

2in 2025

2007: 12010: 22011: 192012: 132013: 322014: 222015: 12017: 42018: 12019: 42023: 32024: 42025: 2
2007high 32 (2013) · low 0 (2008)2025

MAUDE reports naming product code FMW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—21
20080—00
20090—00
20100—02
20110—019
20120—013
20130—032
20140—022
20150—01
20161—00
20170—04
20180—01
20190—04
20200—00
20210—00
20220—00
20230—03
20240—04
20250—02
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K903382

1 other device cites the same predicate.

  • K061242Dermatherapy, Model 22216Precision Fabrics Group, Inc. · 2007

Recent decisions in FMW

The FMW category page

  • K152884DermaTherapy Bed LinensPrecision Fabrics Group, Inc. · 2016
  • K061242Dermatherapy, Model 22216Precision Fabrics Group, Inc. · 2007
  • K992702Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding…Allergy Direct · 1999
  • K940327Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview…W. L. Gore & Associates, Inc. · 1994
  • K935220Core Prevent Mattress ModificationPaladin Medical, Inc. · 1993

https://510kreport.com/device/K001003 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001003: Z-NET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001003

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026