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) Official FDA 510(k) Summary (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.

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

All 9
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
INCOS 50 MASS SPECTROMETER
K880418 · Finnigan Corp. · May 1988
ION TRAP DETECTOR
K880090 · Finnigan Corp. · Mar 1988
FINNIGAN MAT TSQ-70
K880089 · Finnigan Corp. · Feb 1988
ION TRAP DETECTOR (ITD)
K872464 · The Perkin-Elmer Corp. · Aug 1987
MGA 2000 GAS ANALYSER
K854076 · Airspec , Ltd. · Dec 1985
K992163 · ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
Download PDF FDA Summary Pdz-Europa , Ltd.