LZH · Class II · 21 CFR 880.5725

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 3 in the prior period
Consistent review times: 154d avg (recent)

FDA 510(k) Cleared Pump, Infusion, Enteral Devices (Product Code LZH)

34 devices
1–24 of 34
Cleared Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
K253558
Luminoah
General Hospital · 154d
Cleared Oct 23, 2023
Vesco Q™ Enteral Feeding Pump
K232205
Vesco Medical, LLC
General Hospital · 90d
Cleared Dec 20, 2022
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603
Cardinal Health, LLC
General Hospital · 201d
Cleared Nov 10, 2022
AMSure Enteral Feeding Pump
K220230
Amsino International, Inc.
General Hospital · 287d
Cleared Sep 25, 2020
PUGGLE Enteral Feeding Pump and Feeding Set
K200051
Amsino International, Inc.
General Hospital · 259d
Cleared Jul 06, 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074
Covidien
General Hospital · 258d
Cleared May 29, 2015
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263
Covidien
General Hospital · 197d
Cleared Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479
Covidien
General Hospital · 202d
Cleared Feb 12, 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154
Zevex, Inc.
General Hospital · 294d
Cleared Jan 13, 2012
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381
Acacia, Inc.
General Hospital · 241d
Cleared Jun 23, 2006
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K060316
Fresenius Kabi Deutschland GmbH
General Hospital · 135d
Cleared Aug 13, 1998
CLEARSTAR ENTERAL NUTRITION PUMP
K981541
Frantz Medical Development, Ltd.
General Hospital · 106d
Cleared Apr 15, 1996
ENTERALITE
K954735
Zevex Intl., Inc.
General Hospital · 182d
Cleared Mar 21, 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168
Ivac Corporation
General Hospital · 458d
Cleared Mar 07, 1995
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964
Sherwood Medical Co.
General Hospital · 90d
Cleared Feb 01, 1995
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940555
Sandoz Nutrition
General Hospital · 359d
Cleared Nov 07, 1994
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556
Sandoz Nutrition
General Hospital · 273d
Cleared May 13, 1993
FLO-GARD 2100 - 2M8281M
K923066
Baxter Healthcare Corp
General Hospital · 322d
Cleared Feb 07, 1992
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958
Abbott Laboratories
General Hospital · 155d
Cleared Nov 29, 1991
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
K913413
Sherwood Medical Co.
General Hospital · 121d
Cleared Sep 12, 1989
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575
Sandoz Nutrition
General Hospital · 176d

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 3 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 →