Cleared Traditional

K872181 - ETHANOL CALIBRATOR

K872181 is the FDA 510(k) clearance for ETHANOL CALIBRATOR by American Monitor Corp.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K872181 · American Monitor Corp. · Toxicology device
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Jul 1987
Decision
43d
Days
Class 2
Risk

K872181 is an FDA 510(k) clearance for the ETHANOL CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology device 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 American Monitor Corp. devices

Submission Details

510(k) Number K872181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date July 21, 1987
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 87d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K872181.
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · Em Diagnostic Systems, Inc. · Nov 1987
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K874102 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · Em Diagnostic Systems, Inc. · Oct 1987
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K871423 · Sigma Diagnostics, Inc. · Jun 1987
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