Cleared Traditional

PRE-DENT SYSTEM (K800736) - FDA 510(k) Clearance

Class I Hematology device.

K800736 · Pre-Dent System · Hematology device
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Apr 1980
Decision
22d
Days
Class 1
Risk

K800736 is an FDA 510(k) clearance for the PRE-DENT SYSTEM. Classified as Supplies, Blood-bank (product code KSS), Class I - General Controls.

Submitted by Pre-Dent System (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9050 - 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 Pre-Dent System devices

Submission Details

510(k) Number K800736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1980
Decision Date April 24, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KSS Supplies, Blood-bank
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9050
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.