Cleared Traditional

K834526 - MAST INHALANT PROFILE

K834526 is an FDA 510(k) clearance for MAST INHALANT PROFILE, manufactured by Mast Immunosystems. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K834526

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
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 232
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