Cleared Traditional

KM-KAL L1 (K823042) - FDA 510(k) Clearance

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

K823042 · Kmn Products, Inc. · Chemistry device
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Nov 1982
Decision
21d
Days
Class 2
Risk

K823042 is an FDA 510(k) clearance for the KM-KAL L1. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Kmn Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982 after a review of 21 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 K823042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1982
Decision Date November 05, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 107
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K823042.
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K832695 · Bio-Rad · Oct 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · Miles Laboratories, Inc. · Aug 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030 · Roche Diagnostic Systems, Inc. · May 1983
BECKMAN ICS CALIBRATOR
K812649 · Beckman Instruments, Inc. · Oct 1981
HITACHI 705 CALIBRATOR
K811921 · Boehringer Mannheim Corp. · Jul 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · Boehringer Mannheim Corp. · Apr 1981