Cleared Traditional

SDI PREPAX COUNTAPETTE KIT (K892658) - FDA 510(k) Clearance

Class I Hematology device.

K892658 · Scientific Distributors, Inc. · Hematology device
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May 1989
Decision
41d
Days
Class 1
Risk

K892658 is an FDA 510(k) clearance for the SDI PREPAX COUNTAPETTE KIT. Classified as Fluid, Diluting, Manual Cell (product code JCG), Class I - General Controls.

Submitted by Scientific Distributors, Inc. (Norwood, US). The FDA issued a Cleared decision on May 24, 1989 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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 Scientific Distributors, Inc. devices

Submission Details

510(k) Number K892658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date May 24, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JCG Fluid, Diluting, Manual Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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.