Cleared Traditional

K111204 - CELL-DYN 22 PLUS CALIBRATOR

K111204 is the FDA 510(k) clearance for CELL-DYN 22 PLUS CALIBRATOR by Streck. It is a Class 2 Hematology device (product code KRX) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K111204 · Streck · Hematology device
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
237d
Days
Class 2
Risk

K111204 is an FDA 510(k) clearance for the CELL-DYN 22 PLUS CALIBRATOR. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on December 22, 2011 after a review of 237 days - an extended review 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: 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 Streck devices

Submission Details

510(k) Number K111204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date December 22, 2011
Days to Decision 237 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 113d · This submission: 237d
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 8
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K111204.
XN CAL
K160585 · Streck · Dec 2016
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
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · R&D Systems, Inc. · Jul 1991
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · R&D Systems, Inc. · Aug 1986