IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD— 510(k) K913658

Name: FDA 510(k) clearance K913658
Creator: U.S. Food and Drug Administration
Published: 1992-03-26

Substantially Equivalent

Imed Corp.

FDA 510(k) clearance K913658 for IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD, Substantially Equivalent on 1992-03-26. Applicant: Imed Corp.. Device class: 2.

Clearance details

Applicant: Imed Corp.
Product code: Product code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1991-07-29
Decision date: 1992-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K151650 — SMARTez elastomeric infusion pump2016-04-04

More clearances from Imed Corp.

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K960512 — GEMINI PC-ITX1996-11-21
K953896 — THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS1996-03-20
K950153 — VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES1995-08-24
K951922 — ADMINISTRATION SETS WITH BALL FLOAT1995-07-19
K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS1995-06-21

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.