Cleared Traditional

K862964 - ANTIASTHMATIC CALIBRATORS

K862964 is an FDA 510(k) clearance for ANTIASTHMATIC CALIBRATORS, manufactured by American Monitor Corp.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K862964 · American Monitor Corp. · Toxicology device
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Aug 1986
Decision
13d
Days
Class 2
Risk

K862964 is an FDA 510(k) clearance for the ANTIASTHMATIC CALIBRATORS. 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 August 19, 1986 after a review of 13 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

FDA 510(k) Submission Details - K862964

510(k) Number K862964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1986
Decision Date August 19, 1986
Days to Decision 13 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
74d faster than avg
Panel avg: 87d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K862964.
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390 · Windsor Laboratories, Inc. · Apr 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · Em Diagnostic Systems, Inc. · Feb 1987
AMIKACIN (FPIA) CALIBRATOR KIT
K863244 · Windsor Laboratories, Inc. · Aug 1986
EMIT COLUMN DIGOXIN CALIBRATORS
K861395 · Syva Co. · May 1986
DU PONT DIGOXIN ASSAY CALIBRATOR
K850457 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
DU PONT TOBRAMYCIN ASSAY CALIBRATOR
K850057 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985