Cleared Special

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163) - FDA 510(k) Clearance

Class I Toxicology device.

K992163 · Pdz-Europa , Ltd. · Toxicology device
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Jul 1999
Decision
18d
Days
Class 1
Risk

K992163 is an FDA 510(k) clearance for the ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Pdz-Europa , Ltd. (Concord, US). The FDA issued a Cleared decision on July 13, 1999 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pdz-Europa , Ltd. devices

Submission Details

510(k) Number K992163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1999
Decision Date July 13, 1999
Days to Decision 18 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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.