Cleared Traditional

K955375 - EASYSTAT SODIUM/POTASSIUM ANALYZER

K955375 is an FDA 510(k) clearance for EASYSTAT SODIUM/POTASSIUM ANALYZER, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955375 · Medica Corp. · Chemistry device
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Feb 1996
Decision
91d
Days
Class 2
Risk

K955375 is an FDA 510(k) clearance for the EASYSTAT SODIUM/POTASSIUM ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on February 23, 1996 after a review of 91 days - within the typical 510(k) review window.

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 Medica Corp. devices

FDA 510(k) Submission Details - K955375

510(k) Number K955375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date February 23, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

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 131
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K955375.
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · Sigma Diagnostics, Inc. · Sep 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
K955374 · Medica Corp. · Feb 1996
SYNERMED ISE REAGENTS
K952179 · Synermed, Inc. · Jun 1995
EML 100
K935120 · Radiometer America, Inc. · Apr 1994
SYNERMED ISE REAGENTS
K941400 · Synermed, Inc. · Apr 1994