DMRX 100ml Empty Container Solution +3 more— 510(k) K250459

Name: FDA 510(k) clearance K250459
Creator: U.S. Food and Drug Administration
Published: 2025-04-18

Substantially Equivalent

Technoflex Sas.

FDA 510(k) clearance K250459 for DMRX 100ml Empty Container Solution +3 more, Substantially Equivalent on 2025-04-18. Applicant: Technoflex Sas.. Device class: 2.

Clearance details

Device name as filed: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
Applicant: Technoflex Sas.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 2025-02-18
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bidart, FR

Download summary PDF View on FDA.gov ↗

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K252094 — eZSURE Empty Fluid Container2025-08-01
K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site2024-06-21

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.