Cleared Traditional

K010470 - R & D 4K RETIC

K010470 is an FDA 510(k) clearance for R & D 4K RETIC, 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 80-day FDA review.

K010470 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
80d
Days
Class 2
Risk

K010470 is an FDA 510(k) clearance for the R & D 4K RETIC. 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 May 11, 2001 after a review of 80 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 - K010470

510(k) Number K010470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date May 11, 2001
Days to Decision 80 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
33d faster than avg
Panel avg: 113d · This submission: 80d
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 K010470.
R&D RET-LINE KIT
K013898 · R&D Systems, Inc. · Jan 2002
IMMUNO-TROL LOW CELLS
K013842 · Beckman Coulter, Inc. · Dec 2001
PARA 5X
K011410 · Streck Laboratories, Inc. · Jun 2001
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc. · Apr 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · Quantimetrix Corp. · Mar 2001
CBC-SF
K010409 · R&D Systems, Inc. · Mar 2001