Cleared Traditional

K901042 - IONOMETER EF-HK AND ACCESSORIES

K901042 is an FDA 510(k) clearance for IONOMETER EF-HK AND ACCESSORIES, manufactured by Fresenius USA, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K901042 · Fresenius USA, Inc. · Chemistry device
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Jul 1990
Decision
147d
Days
Class 2
Risk

K901042 is an FDA 510(k) clearance for the IONOMETER EF-HK AND ACCESSORIES. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 147 days - within the typical 510(k) review window.

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: 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 - K901042

510(k) Number K901042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1990
Decision Date July 31, 1990
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

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 129
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K901042.
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
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SECONDARY CALIBRATORS
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ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
IONOMETER EH-F AND ACCESSORIES
K901040 · Fresenius USA, Inc. · Jul 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · Baxter Healthcare Corp · Jan 1990
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · Medica Corp. · Dec 1989