510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840767Substantially Equivalent

Haemofuge a. Biofuge a. & B

Heraeus-Christ GmbH, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840767 is the FDA 510(k) clearance record for HAEMOFUGE A. BIOFUGE A. & B, a class II device, cleared for Heraeus-Christ GmbH on under FDA product code JPI (Device, Hematocrit Measuring). FDA records list 2 510(k) clearances for Heraeus-Christ GmbH, from to . As of , FDA records show no recalls naming K840767.

Clearance record

Decision date
Received
(54 days to decision)
Product code
JPI Device, Hematocrit Measuring
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Heraeus-Christ GmbH 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JPI

Trailing 12 months

FDA records hold no clearances under product code JPI in the trailing twelve months.

FDA records show no clearances under product code JPI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260