URINARY DRAINAGE CONTAINER— 510(k) K834448

Name: FDA 510(k) clearance K834448
Creator: U.S. Food and Drug Administration
Published: 1984-02-10

Substantially Equivalent

Vital Metrics, Inc.

FDA 510(k) clearance K834448 for URINARY DRAINAGE CONTAINER, Substantially Equivalent on 1984-02-10. Applicant: Vital Metrics, Inc.. Device class: 2.

Clearance details

Applicant: Vital Metrics, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1983-12-16
Decision date: 1984-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K844973 — IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES1985-03-18
K843441 — URINARY DRAINAGE CONTAINER 2012-WITH1985-01-03
K843442 — URINARY DRAINAGE CONTAINER 2013 WITH1985-01-03

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.