Cleared Traditional

K864872 - MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER

K864872 is the FDA 510(k) clearance for MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER by Medica Corp.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K864872 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
91d
Days
Class 2
Risk

K864872 is an FDA 510(k) clearance for the MEDICA EASYLYTE 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 March 13, 1987 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

Submission Details

510(k) Number K864872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date March 13, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 79
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K864872.
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · Ciba Corning Diagnostics Corp. · Jul 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K872190 · Nova Biomedical Corp. · Jun 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · Ciba Corning Diagnostics Corp. · May 1987
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · Boehringer Mannheim Corp. · Jul 1986
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985