510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011868Substantially Equivalent

Enteral Expres Pump Unit, Enteral Expres Giving Sets

Debio Tech SA, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011868 is the FDA 510(k) clearance record for ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS, a class II device, cleared for Debio Tech SA on under FDA product code LZH (Pump, Infusion, Enteral). FDA records list one 510(k) clearance for Debio Tech SA. As of , FDA records show no recalls naming K011868.

Clearance record

Decision date
Received
(82 days to decision)
Product code
LZH Pump, Infusion, Enteral
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Debio Tech SA 16787 Bernardo Center Dr.,, San Diego CA
510(k) summary
Summary
Third party review
No

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