510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K911636Substantially Equivalent

Genesis(tm) Infusion System

Norman'S, Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911636 is the FDA 510(k) clearance record for GENESIS(TM) INFUSION SYSTEM, a class II device, cleared for Norman'S on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list one 510(k) clearance for Norman'S. As of , FDA records show no recalls naming K911636.

Clearance record

Decision date
Received
(463 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Norman'S 1111 Granville, Newport Beach CA
Third party review
No

Clearances, product code MEB

Trailing 12 months
1 clearance under product code MEB 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 MEB, 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