Cleared Traditional

K912357 - 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE

K912357 is the FDA 510(k) clearance for 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE by R&D Systems, Inc.. It is a Class 2 Hematology device (product code KRX) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K912357 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
42d
Days
Class 2
Risk

K912357 is an FDA 510(k) clearance for the 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE. 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 July 9, 1991 after a review of 42 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. 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

Submission Details

510(k) Number K912357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date July 09, 1991
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - KRX Calibrator For Cell Indices

All 7
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K912357.
CAL-CHEX CD PLUS
K020469 · Streck Laboratories, Inc. · Apr 2002
CD-CAL PLUS CALIBRATOR
K003991 · R&D Systems, Inc. · Jan 2001
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · R&D Systems, Inc. · Feb 1996
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · R&D Systems, Inc. · Aug 1986
DADE HEMATOLOGY CALIBRATOR
K831140 · American Dade · Jun 1983
CELL-CHEX RBC
K811741 · Streck Laboratories, Inc. · Sep 1981