Cleared Traditional

K901041 - IONOMETER EH-HK AND ACCESSORIES

K901041 is an FDA 510(k) clearance for IONOMETER EH-HK AND ACCESSORIES, manufactured by Fresenius USA, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K901041 · Fresenius USA, Inc. · Chemistry device
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Jun 1990
Decision
104d
Days
Class 2
Risk

K901041 is an FDA 510(k) clearance for the IONOMETER EH-HK AND ACCESSORIES. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 104 days - within the typical 510(k) review window.

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 Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K901041

510(k) Number K901041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1990
Decision Date June 18, 1990
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 64
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K901041.
NOVA 11 NA/K/LI ANALYZER
K915178 · Nova Biomedical Corp. · Jan 1992
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991
IONOMETER EH
K901039 · Fresenius USA, Inc. · Jun 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · Baxter Healthcare Corp · Mar 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