Cleared Abbreviated

K254123 - Ecomed Disposable Administration Sets

K254123 is an FDA 510(k) clearance for Ecomed Disposable Administration Sets, manufactured by Ecomed Solutions, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 266-day FDA review.

K254123 · Ecomed Solutions, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
266d
Days
Class 2
Risk

K254123 is an FDA 510(k) clearance for the Ecomed Disposable Administration Sets. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ecomed Solutions, LLC (Lindenhurst, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ecomed Solutions, LLC devices

FDA 510(k) Submission Details - K254123

510(k) Number K254123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date September 11, 2026
Days to Decision 266 days
Submission Type Abbreviated
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
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Standards-based clearance path.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.

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All 871
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