510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060316Substantially Equivalent

Compat Go Enteral Feeding Pump and Administration Sets

Fresenius Kabi Deutschland GmbH, Bad Homburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060316 is the FDA 510(k) clearance record for COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS, a class II device, cleared for Fresenius Kabi Deutschland GmbH on under FDA product code LZH (Pump, Infusion, Enteral). FDA records list one 510(k) clearance for Fresenius Kabi Deutschland GmbH. As of , FDA records show no recalls naming K060316.

Clearance record

Decision date
Received
(135 days to decision)
Product code
LZH Pump, Infusion, Enteral
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Fresenius Kabi Deutschland GmbH Daimlerstrasse 22, Bad Homburg, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LZH

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