Cleared Traditional

K843694 - MAST ALLERGY SYSTEM

K843694 is an FDA 510(k) clearance for MAST ALLERGY SYSTEM, 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 205-day FDA review.

K843694 · Mast Immunosystems · Immunology device
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Apr 1985
Decision
205d
Days
Class 2
Risk

K843694 is an FDA 510(k) clearance for the MAST ALLERGY SYSTEM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Mast Immunosystems (Mountain View, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 205 days - an extended review 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: 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 - K843694

510(k) Number K843694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1984
Decision Date April 12, 1985
Days to Decision 205 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 105d · This submission: 205d
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 K843694.
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · Pharmacia, Inc. · Jul 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · Pharmacia, Inc. · Jun 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · Pharmacia, Inc. · May 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · Pharmacia, Inc. · Mar 1985
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · Pharmacia, Inc. · Jul 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · Ventrex Laboratories, Inc. · May 1984