Cleared Traditional

K863617 - ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

K863617 is the FDA 510(k) clearance for ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) by Hi Chem, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K863617 · Hi Chem, Inc. · Chemistry device
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Oct 1986
Decision
38d
Days
Class 2
Risk

K863617 is an FDA 510(k) clearance for the ION 2/4 FLOW CELL CLEANER (PRODUCT #88656). Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 38 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 Hi Chem, Inc. devices

Submission Details

510(k) Number K863617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date October 24, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 111
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K863617.
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
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · Medica Corp. · Mar 1987
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · Boehringer Mannheim Corp. · Jul 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET
K861967 · American Research Products Co. · Jun 1986
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985