Cleared Traditional

K915345 - STAT K SYSTEM

K915345 is an FDA 510(k) clearance for STAT K SYSTEM, manufactured by Portable Diagnostic Services, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K915345 · Portable Diagnostic Services, Inc. · Chemistry device
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Jul 1992
Decision
233d
Days
Class 2
Risk

K915345 is an FDA 510(k) clearance for the STAT K SYSTEM. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Portable Diagnostic Services, Inc. (Westlake Village, US). The FDA issued a Cleared decision on July 16, 1992 after a review of 233 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Portable Diagnostic Services, Inc. devices

FDA 510(k) Submission Details - K915345

510(k) Number K915345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date July 16, 1992
Days to Decision 233 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 88d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 71
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K915345.
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044 · Dupont Medical Products · Jul 1993
NOVA NA/K/CL/LI MODULE
K922943 · Nova Biomedical Corp. · Oct 1992
MILES POTASSIUM METHOD
K923038 · Heraeus Kulzer, Inc. · Aug 1992
NOVA 5 NA/K/C1 ALALYZER
K915177 · Nova Biomedical Corp. · Jan 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · Nova Biomedical Corp. · Jan 1992
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991