Cleared Traditional

K851403 - VENTREZYME ALLERGEN DATA REDUCTION SYSTEM

K851403 is the FDA 510(k) clearance for VENTREZYME ALLERGEN DATA REDUCTION SYSTEM by Ventrex Laboratories, Inc.. It is a Class 1 Immunology device (product code JQW) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K851403 · Ventrex Laboratories, Inc. · Immunology device
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Jun 1985
Decision
73d
Days
Class 1
Risk

K851403 is an FDA 510(k) clearance for the VENTREZYME ALLERGEN DATA REDUCTION SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on June 21, 1985 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2750 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K851403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date June 21, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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.

Regulatory Peers - JQW Station, Pipetting And Diluting, For Clinical Use

All 63
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K851403.
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