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 (intravascular administration sets). The record doesn't describe the set configurations.
Class II, 21 CFR 880.5440, General Hospital panel. This one used the Abbreviated 510(k) pathway.
Ecomed Solutions filed from Lindenhurst, Illinois. Review took 266 days (December 19, 2025 to September 11, 2026).
Clearance details
- Applicant
- Ecomed Solutions, LLC
- Product code
- Product 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- K260261 — Gravity Blood Sets with 200µm Filter
- 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
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.