FDA Product Code LZH: Pump, Infusion, Enteral

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

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 →

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