Cleared Traditional

K834099 - BLOOD GLUCOSE MONITOR

K834099 is the FDA 510(k) clearance for BLOOD GLUCOSE MONITOR by Healthdyne, Inc.. It is a Class 1 Hematology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834099 · Healthdyne, Inc. · Hematology device
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Feb 1984
Decision
67d
Days
Class 1
Risk

K834099 is an FDA 510(k) clearance for the BLOOD GLUCOSE MONITOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2300 - the FDA hematology 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 Healthdyne, Inc. devices

Submission Details

510(k) Number K834099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date February 03, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 72
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K834099.
SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER
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ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER
K843460 · Varian Assoc., Inc. · Sep 1984
ORTHO MICROWELL READER
K841557 · Ortho Diagnostic Systems, Inc. · May 1984
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · Varian Assoc., Inc. · Jul 1983
MANUALISA MICROTITRATION PLATE READER
K823590 · Ortho Diagnostic Systems, Inc. · Feb 1983
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982