Cleared Traditional

K831079 - LIQUIPETTE (FDA 510(k) Clearance)

Class I Hematology device.

K831079 · The Kendall Company Div. of Tyco Healthcare Group · Hematology device
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Apr 1983
Decision
24d
Days
Class 1
Risk

K831079 is an FDA 510(k) clearance for the LIQUIPETTE. Classified as Pipette, Quantitative, Hematology (product code GJG), Class I - General Controls.

Submitted by The Kendall Company Div. of Tyco Healthcare Group (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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 The Kendall Company Div. of Tyco Healthcare Group devices

Submission Details

510(k) Number K831079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date April 28, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GJG Pipette, Quantitative, Hematology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
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.