Cleared Traditional

CELLTRAK-B (K834585) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834585 · R&D Systems, Inc. · Hematology device
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May 1984
Decision
125d
Days
Class 2
Risk

K834585 is an FDA 510(k) clearance for the CELLTRAK-B. Classified as Device, Patient Transfer, Powered (product code FRZ), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 880.6775 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all R&D Systems, Inc. devices

Submission Details

510(k) Number K834585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date May 02, 1984
Days to Decision 125 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 113d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRZ Device, Patient Transfer, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6775
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 Hematology devices follow this clearance model.