Cleared Special

CD-CAL PLUS CALIBRATOR (K003991) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003991 · R&D Systems, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jan 2001
Decision
21d
Days
Class 2
Risk

K003991 is an FDA 510(k) clearance for the CD-CAL PLUS CALIBRATOR. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 16, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8150 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all R&D Systems, Inc. devices

Submission Details

510(k) Number K003991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date January 16, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRX Calibrator For Cell Indices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8150
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.