Cleared Traditional

KM - KAL 2 (K823025) - FDA 510(k) Clearance

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

K823025 · Kmn Products, Inc. · Chemistry device
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Nov 1982
Decision
34d
Days
Class 2
Risk

K823025 is an FDA 510(k) clearance for the KM - KAL 2. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Kmn Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Kmn Products, Inc. devices

Submission Details

510(k) Number K823025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1982
Decision Date November 16, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 95
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K823025.
CARBON DIOXIDE CALIBRATOR II
K840775 · American Dade · Apr 1984
ACA THYROXINE UPTAKE CALIBRATOR
K833702 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
ACA THYROXINE CALIBRATOR
K833700 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
DUAL COMPONENT STANDARDS
K781423 · Abbott Laboratories · Aug 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1978
ACA TRIGLYCERIDE CALIBRATOR
K771797 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977