FDA Product Code LZH: Pump, Infusion, Enteral
Leading manufacturers include Amsino International, Inc. and Luminoah.
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
Cleared
Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
Luminoah
General Hospital
154d
Cleared
Nov 10, 2022
AMSure Enteral Feeding Pump
Amsino International, Inc.
General Hospital
287d
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 Review Time
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 →