Cleared Traditional

Z-NET (K001003) - FDA 510(k) Clearance

Class I General Hospital device.

K001003 · Demite Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
621d
Days
Class 1
Risk

K001003 is an FDA 510(k) clearance for the Z-NET. Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Demite Limited (Washington, US). The FDA issued a Cleared decision on December 10, 2001 after a review of 621 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

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Submission Details

510(k) Number K001003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date December 10, 2001
Days to Decision 621 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
492d slower than avg
Panel avg: 129d · This submission: 621d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.