Cleared Traditional

K963763 - EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER

K963763 is an FDA 510(k) clearance for EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITH..., 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 71-day FDA review.

K963763 · Medica Corp. · Chemistry device
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Nov 1996
Decision
71d
Days
Class 2
Risk

K963763 is an FDA 510(k) clearance for the EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM 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 November 29, 1996 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medica Corp. devices

FDA 510(k) Submission Details - K963763

510(k) Number K963763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date November 29, 1996
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K963763.
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