Cleared Traditional

K863959 - OHMEDA 6000 MULTI-GAS MONITOR

K863959 is an FDA 510(k) clearance for OHMEDA 6000 MULTI-GAS MONITOR, manufactured by Ohmeda Medical. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K863959 · Ohmeda Medical · Chemistry device
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Jan 1987
Decision
94d
Days
Class 1
Risk

K863959 is an FDA 510(k) clearance for the OHMEDA 6000 MULTI-GAS MONITOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ohmeda Medical devices

FDA 510(k) Submission Details - K863959

510(k) Number K863959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date January 12, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 165
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K863959.
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · Ciba Corning Diagnostics Corp. · May 1987
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · Dynatech Laboratories, Inc. · Apr 1987
ADX(TM) ANALYZER
K864566 · Abbott Laboratories · Feb 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
AP1 COLORIMETER
K864634 · Awareness Technology, Inc. · Dec 1986
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986