GENESIS(TM) INFUSION SYSTEM— 510(k) K911636

Name: FDA 510(k) clearance K911636
Creator: U.S. Food and Drug Administration
Published: 1992-07-17

Substantially Equivalent

Norman'S

FDA 510(k) clearance K911636 for GENESIS(TM) INFUSION SYSTEM, Substantially Equivalent on 1992-07-17. Applicant: Norman'S. Device class: 2.

Clearance details

Applicant: Norman'S
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1991-04-11
Decision date: 1992-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEB

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K250234 — SMARTeZ Elastomeric Infusion Pump (RS series)2026-04-24
K240624 — InfuLife2024-11-05
K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)2024-10-07
K181360 — ON-Q* Pump with Bolus2019-03-22
K151650 — SMARTez elastomeric infusion pump2016-04-04

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.