Cleared Traditional

K811289 - NOVA 5

K811289 is the FDA 510(k) clearance for NOVA 5 by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K811289 · Nova Biomedical Corp. · Chemistry device
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May 1981
Decision
16d
Days
Class 2
Risk

K811289 is an FDA 510(k) clearance for the NOVA 5. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 16 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K811289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date May 27, 1981
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 99
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K811289.
LIQUIZYME NA+/K+ REAGENT SET
K820395 · American Research Products Co. · Mar 1982
IL 501, NA/K ANALYZER
K812762 · Instrumentation Laboratory CO · Oct 1981
902 NA/K
K811896 · Corning Medical & Scientific · Jul 1981
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
K801795 · J.T. Baker Chemical Co. · Sep 1980
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · Nova Biomedical Corp. · Sep 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · Beckman Instruments, Inc. · Sep 1980