Cleared Traditional

K810938 - MASS SPECTROMETER-MEDSPECT II (FDA 510(k) Clearance)

Class I Toxicology device.

K810938 · Allied Healthcare Products, Inc. · Toxicology device
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Apr 1981
Decision
16d
Days
Class 1
Risk

K810938 is an FDA 510(k) clearance for the MASS SPECTROMETER-MEDSPECT II. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Allied Healthcare Products, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2860 - the FDA toxicology 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 Allied Healthcare Products, Inc. devices

Submission Details

510(k) Number K810938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date April 23, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DOP Mass Spectrometer, Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2860
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.