Cleared Traditional

IRON (K854298) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854298 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1985
Decision
18d
Days
Class 2
Risk

K854298 is an FDA 510(k) clearance for the IRON. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 18 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K854298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 12, 1985
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 28
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K854298.
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
VISION LYTE (TM) POTASSIUM
K884566 · Abbott Laboratories · Dec 1988
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · American Dade · Sep 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · Miles Laboratories, Inc. · Mar 1985