Cleared Traditional

EML 100 (K935120) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935120 · Radiometer America, Inc. · Chemistry device
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Apr 1994
Decision
181d
Days
Class 2
Risk

K935120 is an FDA 510(k) clearance for the EML 100. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 181 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Radiometer America, Inc. devices

Submission Details

510(k) Number K935120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date April 26, 1994
Days to Decision 181 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 88d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 54
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K935120.
BAYER ADVIA 1650 CHEMISTRY SYSTEM
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(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
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SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · Sigma Diagnostics, Inc. · Sep 1996
CIBA CORNING 300 SERIES SYSTEM
K933373 · Ciba Corning Diagnostics Corp. · Aug 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · Eastman Kodak Company · Nov 1992
OLYMPUS ISE MODULE
K921718 · Olympus Corp. · Jul 1992