Cleared Traditional

K880418 - INCOS 50 MASS SPECTROMETER

K880418 is an FDA 510(k) clearance for INCOS 50 MASS SPECTROMETER, manufactured by Finnigan Corp.. The device is a Class 1 Toxicology device with product code DOP cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K880418 · Finnigan Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
120d
Days
Class 1
Risk

K880418 is an FDA 510(k) clearance for the INCOS 50 MASS SPECTROMETER. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Finnigan Corp. (Livingston, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Finnigan Corp. devices

FDA 510(k) Submission Details - K880418

510(k) Number K880418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date May 31, 1988
Days to Decision 120 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 87d · This submission: 120d
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 K880418.
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
K992163 · Pdz-Europa , Ltd. · Jul 1999
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
K974322 · Europa Scientific, Ltd. · Dec 1997
ION TRAP DETECTOR (ITD)
K872464 · The Perkin-Elmer Corp. · Aug 1987
MASS SPECTROMETER-MEDSPECT II
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