Cleared Traditional

K841516 - VENTRESCREEN

K841516 is the FDA 510(k) clearance for VENTRESCREEN by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K841516 · Ventrex Laboratories, Inc. · Immunology device
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May 1984
Decision
29d
Days
Class 2
Risk

K841516 is an FDA 510(k) clearance for the VENTRESCREEN, MULTIPLE ALLERGEN DISCS. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 K841516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1984
Decision Date May 11, 1984
Days to Decision 29 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
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K841516.
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PHADEBAS RAST PHADEZYM MIX ALLERG
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PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · Pharmacia, Inc. · Apr 1984
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K840537 · Pharmacia, Inc. · Apr 1984