Cleared Traditional

K920949 - SOFTWARE MODIFICATION FOR MILES H*1 S/W...

K920949 is the FDA 510(k) clearance for SOFTWARE MODIFICATION FOR MILES H*1 S/W... by Heraeus Kulzer, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K920949 · Heraeus Kulzer, Inc. · Hematology device
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May 1992
Decision
74d
Days
Class 2
Risk

K920949 is an FDA 510(k) clearance for the SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K920949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date May 15, 1992
Days to Decision 74 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
39d faster than avg
Panel avg: 113d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 225
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K920949.
COULTER MH009
K922181 · Coulter Electronics, Inc. · Aug 1992
COULTER MAXM W/ AUTOLOADER
K922704 · Coulter Electronics, Inc. · Jul 1992
COULTER MH017
K921567 · Coulter Electronics, Inc. · Jul 1992
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
K920544 · Toa Medical Electronics USA, Inc. · Apr 1992
SIMULTEST(TM) IMK-LYMPHOCYTE
K913192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SYSMEX NE-1500, MODIFICATION
K914744 · Toa Medical Electronics USA, Inc. · Dec 1991