Cleared Special

K992163 - ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

K992163 is an FDA 510(k) clearance for ABCA GAS ISOTOPE RATIO MASS SPECTROMETE..., manufactured by Pdz-Europa , Ltd.. The device is a Class 1 Toxicology device with product code DOP cleared through the Special 510(k) pathway after a 18-day FDA review.

K992163 · Pdz-Europa , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K992163

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 K992163.
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
K974322 · Europa Scientific, Ltd. · Dec 1997
ION TRAP DETECTOR (ITD)
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K810938 · Allied Healthcare Products, Inc. · Apr 1981
FURNACE AUTOSAMPLER, MODEL 155
K770994 · Instrumentation Laboratory CO · Aug 1977
MERCURY/HYDRIDE SYSTEM MHS-1
K770637 · The Perkin-Elmer Corp. · Jun 1977