Cleared Traditional

K010409 - CBC-SF

K010409 is an FDA 510(k) clearance for CBC-SF, manufactured by R&D Systems, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K010409 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
32d
Days
Class 2
Risk

K010409 is an FDA 510(k) clearance for the CBC-SF. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 16, 2001 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 R&D Systems, Inc. devices

FDA 510(k) Submission Details - K010409

510(k) Number K010409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date March 16, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 163
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K010409.
R & D 4K RETIC
K010470 · R&D Systems, Inc. · May 2001
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc. · Apr 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · Quantimetrix Corp. · Mar 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · Beckman Coulter, Inc. · Feb 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · Beckman Coulter, Inc. · Feb 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · R&D Systems, Inc. · Jan 2001