510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071909Substantially Equivalent

Prismacomfort, Model Autocontrol 3Xpt with Autoline Xpt 4R

Barkey GmbH & Co. KG, Leopoldshoehe, DE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071909 is the FDA 510(k) clearance record for PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R, a class II device, cleared for Barkey GmbH & Co. KG on under FDA product code KOC (Accessories, Blood Circuit, Hemodialysis). FDA records list 2 510(k) clearances for Barkey GmbH & Co. KG, from to . As of , FDA records show no recalls naming K071909.

Clearance record

Decision date
Received
(99 days to decision)
Product code
KOC Accessories, Blood Circuit, Hemodialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Barkey GmbH & Co. KG Gewerbestrasse 8, Leopoldshoehe, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KOC

Trailing 12 months

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

FDA records show no clearances under product code KOC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOC, 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