Cleared Traditional

K862148 - OLYMPUS AU 5000 FLAME PHOTOMETER MODULE

K862148 is the FDA 510(k) clearance for OLYMPUS AU 5000 FLAME PHOTOMETER MODULE by Olympus Corp.. It is a Class 1 Chemistry device (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

Submission Details

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.

Device Classification

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 11
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