Cleared Traditional

K862148 - OLYMPUS AU 5000 FLAME PHOTOMETER MODULE

K862148 is an FDA 510(k) clearance for OLYMPUS AU 5000 FLAME PHOTOMETER MODULE, manufactured by Olympus Corp.. The device is a Class 1 Chemistry device with product code JJO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K862148 · Olympus Corp. · Chemistry device
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Sep 1986
Decision
117d
Days
Class 1
Risk

K862148 is an FDA 510(k) clearance for the OLYMPUS AU 5000 FLAME PHOTOMETER MODULE. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - 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 Olympus Corp. devices

FDA 510(k) Submission Details - K862148

510(k) Number K862148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1986
Decision Date September 29, 1986
Days to Decision 117 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
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

JJO Device Classification - Class 1, General Controls

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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 - JJO Flame Emission Photometer For Clinical Use

All 15
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K862148.
LITHIUM REAGENT
K841847 · Reagent Laboratory, Inc. · Aug 1984
DAILY WASH SOLUTION 5
K841421 · Reagent Laboratory, Inc. · May 1984
VOLUME TEST DYE 6
K841422 · Reagent Laboratory, Inc. · May 1984
SUPPLIES FOR INSTRUMENTATION LAB FLAME
K840530 · Shaban Mfg. Co. · Mar 1984
POTASSIUM SODIUM ANALYSIS PRODUCTS
K833535 · Shaban Mfg. Co. · Dec 1983
SHABAN #9852 CHIMNEY-#9854 SCREEN &
K832931 · Shaban Mfg. Co. · Oct 1983