Cleared Traditional

PYLORISET DRY (K942974) - FDA 510(k) Clearance

Class I Microbiology device.

K942974 · Orion Diagnostica, Div. Orion Corp. · Microbiology device
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Apr 1995
Decision
289d
Days
Class 1
Risk

K942974 is an FDA 510(k) clearance for the PYLORISET DRY. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Orion Diagnostica, Div. Orion Corp. (02101 Espoo, FI). The FDA issued a Cleared decision on April 5, 1995 after a review of 289 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orion Diagnostica, Div. Orion Corp. devices

Submission Details

510(k) Number K942974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date April 05, 1995
Days to Decision 289 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 102d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.

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All 90
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