Cleared Traditional

K915177 - NOVA 5 NA/K/C1 ALALYZER

K915177 is the FDA 510(k) clearance for NOVA 5 NA/K/C1 ALALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K915177 · Nova Biomedical Corp. · Chemistry device
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Jan 1992
Decision
73d
Days
Class 2
Risk

K915177 is an FDA 510(k) clearance for the NOVA 5 NA/K/C1 ALALYZER. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 73 days - a notably fast clearance 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: 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K915177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date January 27, 1992
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K915177.
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
K961326 · Medica Corp. · Jun 1996
NOVA NA/K/CL/LI MODULE
K922943 · Nova Biomedical Corp. · Oct 1992
MILES POTASSIUM METHOD
K923038 · Heraeus Kulzer, Inc. · Aug 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · Nova Biomedical Corp. · Jan 1992
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991
LYTENING 2Z LYTENING SYSTEM 31
K900300 · Baxter Healthcare Corp · Mar 1990