FDA Product Code LZH: Pump, Infusion, Enteral
Leading manufacturers include Covidien, Sandoz Nutrition and Amsino International, Inc..
34
Total
34
Cleared
175d
Avg days
1987
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
154d avg (recent)
FDA 510(k) Cleared Pump, Infusion, Enteral Devices (Product Code LZH)
34 devices
Cleared
Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
Luminoah
General Hospital
154d
Cleared
Oct 23, 2023
Vesco Q™ Enteral Feeding Pump
Vesco Medical, LLC
General Hospital
90d
Cleared
Dec 20, 2022
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
Cardinal Health, LLC
General Hospital
201d
Cleared
Nov 10, 2022
AMSure Enteral Feeding Pump
Amsino International, Inc.
General Hospital
287d
Cleared
Sep 25, 2020
PUGGLE Enteral Feeding Pump and Feeding Set
Amsino International, Inc.
General Hospital
259d
Cleared
Jul 06, 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
Covidien
General Hospital
258d
Cleared
May 29, 2015
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
Covidien
General Hospital
197d
Cleared
Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
Covidien
General Hospital
202d
Cleared
Feb 12, 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
Zevex, Inc.
General Hospital
294d
Cleared
Jan 13, 2012
MEDI-SIS SYRINGE INFUSION SYSTEM
Acacia, Inc.
General Hospital
241d
Cleared
Jun 23, 2006
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
Fresenius Kabi Deutschland GmbH
General Hospital
135d
Cleared
May 21, 2004
NOA III ENTERAL NUTRITION PUMP
Caesarea Medical Electronics , Ltd.
General Hospital
38d
Cleared
May 05, 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
Tyco Healthcare/Kendall
General Hospital
97d
Cleared
Jul 09, 2003
ENTERALITE INFINITY ENTERAL FEEDING PUMP
Zevex Intl., Inc.
General Hospital
86d
Cleared
May 20, 2003
ROSS EMBRACE ENTERAL PUMP
Ross Product Div. Abbott Laboratories
General Hospital
15d
Cleared
Sep 04, 2001
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
Debio Tech SA
General Hospital
82d
Cleared
Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
Ross Product Div. Abbott Laboratories
General Hospital
256d
Cleared
Jun 01, 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
Entracon Corp.
General Hospital
9d
Cleared
Aug 13, 1998
CLEARSTAR ENTERAL NUTRITION PUMP
Frantz Medical Development, Ltd.
General Hospital
106d
Cleared
Apr 15, 1996
ENTERALITE
Zevex Intl., Inc.
General Hospital
182d
Cleared
Mar 21, 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
Ivac Corporation
General Hospital
458d
Cleared
Dec 22, 1995
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
Ross Products
General Hospital
269d
Cleared
Aug 18, 1995
RATESAVER PLUS
Entracare Corp.
General Hospital
67d
Cleared
Mar 07, 1995
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
Sherwood Medical Co.
General Hospital
90d
About Product Code LZH - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code LZH since 1987, with 34 receiving FDA clearance (average review time: 175 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - LZH Product Code
FDA review times for LZH submissions have been consistent, averaging 154 days recently vs 176 days historically.
LZH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →