Cleared Traditional

K834526 - MAST INHALANT PROFILE

K834526 is the FDA 510(k) clearance for MAST INHALANT PROFILE by Mast Immunosystems. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K834526 · Mast Immunosystems · Immunology device
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Apr 1984
Decision
105d
Days
Class 2
Risk

K834526 is an FDA 510(k) clearance for the MAST INHALANT PROFILE. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Mast Immunosystems (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mast Immunosystems devices

Submission Details

510(k) Number K834526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date April 04, 1984
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 104d · This submission: 105d
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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K834526.
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · Ventrex Laboratories, Inc. · May 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670 · Pharmacia, Inc. · Apr 1984
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · Pharmacia, Inc. · Apr 1984
RAST ALLERGO SORBENT TEST
K840537 · Pharmacia, Inc. · Apr 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · Kallestad Laboratories, Inc. · Mar 1984
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K832217 · Ventrex Laboratories, Inc. · Sep 1983