Cleared Traditional

K900300 - LYTENING 2Z LYTENING SYSTEM 31

K900300 is the FDA 510(k) clearance for LYTENING 2Z LYTENING SYSTEM 31 by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K900300 · Baxter Healthcare Corp · Chemistry device
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Mar 1990
Decision
38d
Days
Class 2
Risk

K900300 is an FDA 510(k) clearance for the LYTENING 2Z LYTENING SYSTEM 31. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 38 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K900300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1990
Decision Date March 01, 1990
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 56
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K900300.
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991
IONOMETER EH
K901039 · Fresenius USA, Inc. · Jun 1990
IONOMETER EH-HK AND ACCESSORIES
K901041 · Fresenius USA, Inc. · Jun 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · Baxter Healthcare Corp · Jan 1990
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
K895664 · Technicon Instruments Corp. · Nov 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · Ciba Corning Diagnostics Corp. · Jan 1989