Cleared Traditional

K802856 - MINIATURE ION SELECTIVE ELECTRODES

K802856 is the FDA 510(k) clearance for MINIATURE ION SELECTIVE ELECTRODES by Ionetics, Inc.. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K802856 · Ionetics, Inc. · Chemistry device
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Jan 1981
Decision
77d
Days
Class 2
Risk

K802856 is an FDA 510(k) clearance for the MINIATURE ION SELECTIVE ELECTRODES. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Ionetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Ionetics, Inc. devices

Submission Details

510(k) Number K802856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date January 28, 1981
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 17
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K802856.
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · Nova Biomedical Corp. · Apr 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502 · Nova Biomedical Corp. · Mar 1983
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K823389 · Nova Biomedical Corp. · Feb 1983
NOVA 2 IONIZED CALCIUM ANALYZER
K771643 · Nova Biomedical Corp. · Sep 1977