Cleared Traditional

K896526 - LYTENING(TM) 5

K896526 is the FDA 510(k) clearance for LYTENING(TM) 5 by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K896526 · Baxter Healthcare Corp · Chemistry device
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Jan 1990
Decision
50d
Days
Class 2
Risk

K896526 is an FDA 510(k) clearance for the LYTENING(TM) 5, LYTENING(TM) SYSTEM 30. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 50 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K896526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date January 02, 1990
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K896526.
ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
IONOMETER EF-HK AND ACCESSORIES
K901042 · Fresenius USA, Inc. · Jul 1990
IONOMETER EH-F AND ACCESSORIES
K901040 · Fresenius USA, Inc. · Jul 1990
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · Medica Corp. · Dec 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · Technicon Instruments Corp. · Oct 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · Nova Biomedical Corp. · Sep 1989