510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920949Substantially Equivalent

Software Modification for Miles H*1 S/w Ver. 1.5

Kulzer GmbH, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920949 is the FDA 510(k) clearance record for SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K920949.

Clearance record

Decision date
Received
(74 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Statement
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260