SAMPLE MANIFOLD HOLDER— 510(k) K860889

Name: FDA 510(k) clearance K860889
Creator: U.S. Food and Drug Administration
Published: 1986-04-07

Substantially Equivalent

R. Bell

FDA 510(k) clearance K860889 for SAMPLE MANIFOLD HOLDER, Substantially Equivalent on 1986-04-07. Applicant: R. Bell. Device class: 2.

Clearance details

Applicant: R. Bell
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1986-03-10
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
K223499 — Three Way Stop Cock2023-07-21
K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
K210516 — Clicky Cross2022-05-16

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.