Cleared Traditional

K250459 - DMRX 100ml Empty Container Solution (FDA 510(k) Clearance)

Also includes:
DMRX 250ml Empty Container Solution DMRX 500ml Empty Container Solution DMRX 1000ml Empty Container Solution

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250459 · Technoflex Sas. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
59d
Days
Class 2
Risk

K250459 is an FDA 510(k) clearance for the DMRX 100ml Empty Container Solution. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Technoflex Sas. (Bidart, FR). The FDA issued a Cleared decision on April 18, 2025 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Technoflex Sas. devices

Submission Details

510(k) Number K250459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date April 18, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Mdi Consutants, Inc.
Vaibhav Rajal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPE Container, I.v.

All 116
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