Cleared Traditional

K854076 - MGA 2000 GAS ANALYSER

K854076 is an FDA 510(k) clearance for MGA 2000 GAS ANALYSER, manufactured by Airspec , Ltd.. The device is a Class 1 Toxicology device with product code DOP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K854076 · Airspec , Ltd. · Toxicology device
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Dec 1985
Decision
65d
Days
Class 1
Risk

K854076 is an FDA 510(k) clearance for the MGA 2000 GAS ANALYSER. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Airspec , Ltd. (Tn 16 3bw, England, GB). The FDA issued a Cleared decision on December 11, 1985 after a review of 65 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 Airspec , Ltd. devices

FDA 510(k) Submission Details - K854076

510(k) Number K854076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date December 11, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

DOP Device Classification - Class 1, General Controls

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.

Regulatory Peers - DOP Mass Spectrometer, Clinical Use

Devices cleared under the same product code (DOP) and FDA review panel - the closest regulatory comparables to K854076.
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K872464 · The Perkin-Elmer Corp. · Aug 1987
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K770994 · Instrumentation Laboratory CO · Aug 1977
MERCURY/HYDRIDE SYSTEM MHS-1
K770637 · The Perkin-Elmer Corp. · Jun 1977