Remunity System— 510(k) K240256

Name: FDA 510(k) clearance K240256
Creator: U.S. Food and Drug Administration
Published: 2024-06-12

Substantially Equivalent

Deka Research and Development

FDA 510(k) clearance K240256 for Remunity System, Substantially Equivalent on 2024-06-12. Applicant: Deka Research and Development. Device class: 2.

Clearance details

Applicant: Deka Research and Development
Product code: Code QJY
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2024-01-31
Decision date: 2024-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

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K243354 — Remunity System2024-11-27
K202690 — Remunity Pump for Remodulin (treprostinil) Injection2020-12-30
K191313 — Unity Subcutaneous Infusion System for Remodulin2020-02-21

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Adverse events under product code QJY

product code QJY

Death: 4
Other: 1
Total: 5

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.