Ecomed Disposable Administration Sets— 510(k) K254123
Substantially EquivalentEcomed Solutions, LLC
FDA 510(k) clearance K254123 for Ecomed Disposable Administration Sets, Substantially Equivalent on 2026-09-11. Applicant: Ecomed Solutions, LLC. Device class: 2.
Summary
Ecomed Disposable Administration Sets are IV administration sets, product code FPA: the tubing between the fluid bag and the patient's catheter, with its drip chamber, clamps, and connectors.
Class II, 21 CFR 880.5440, General Hospital panel. This one used the Abbreviated 510(k) pathway, which leans on FDA guidance, special controls, or recognized consensus standards to show equivalence instead of a full predicate comparison. It's much less common than Traditional.
Ecomed Solutions filed from Lindenhurst, Illinois. At 266 days (December 19, 2025 to September 11, 2026), this is slow for an Abbreviated filing on a commodity device. Rounds of FDA questions are a more likely cause than the review itself.
Clearance details
- Applicant
- Ecomed Solutions, LLC
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Lindenhurst, IL, US
Recent devices under product code FPA
view all- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
- K250325 — BD Alaris Pump Infusion Set
More clearances from Ecomed Solutions, LLC
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . 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.