DISPOSABLE DIAPHRAGM DOMES— 510(k) K820355

Name: FDA 510(k) clearance K820355
Creator: U.S. Food and Drug Administration
Published: 1982-03-04

Substantially Equivalent

Medex, Inc.

FDA 510(k) clearance K820355 for DISPOSABLE DIAPHRAGM DOMES, Substantially Equivalent on 1982-03-04. Applicant: Medex, Inc.. Device class: 2.

Clearance details

Applicant: Medex, Inc.
Product code: Code DRS
Device class: Class 2
Regulation: 21 CFR 870.2850
Advisory panel: Cardiovascular
Date received: 1982-02-08
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP2000-05-09
K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP1999-04-06

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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 →

Recalls naming K820355

K-number listed on FDA's recall record

Z-0739-2024 — Medex LOGICAL CATH LAB KIT, List Number M20754Class II·Ongoing·Smiths Medical Asd Inc·20231110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820355.

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