Cleared Traditional

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 (K920949) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 108
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K920949.
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · Heraeus Kulzer, Inc. · May 1993
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
SIMULTEST(TM) IMK-LYMPHOCYTE
K913192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
FACSTRAK FLOW CYTOMETER
K914014 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · Sigma Chemical Co. · Oct 1991