Cleared Traditional

K952179 - SYNERMED ISE REAGENTS

K952179 is the FDA 510(k) clearance for SYNERMED ISE REAGENTS by Synermed, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K952179 · Synermed, Inc. · Chemistry device
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Jun 1995
Decision
42d
Days
Class 2
Risk

K952179 is an FDA 510(k) clearance for the SYNERMED ISE REAGENTS. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on June 20, 1995 after a review of 42 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 Synermed, Inc. devices

Submission Details

510(k) Number K952179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date June 20, 1995
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 115
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K952179.
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
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K955374 · Medica Corp. · Feb 1996
EASYSTAT SODIUM/POTASSIUM ANALYZER
K955375 · Medica Corp. · Feb 1996
EML 100
K935120 · Radiometer America, Inc. · Apr 1994
SYNERMED ISE REAGENTS
K941400 · Synermed, Inc. · Apr 1994
SYNERMED ISE REAGENTS
K940194 · Synermed, Inc. · Apr 1994