510(k) K254123
- Device
- Ecomed Disposable Administration Sets
- Applicant
- Ecomed Solutions, LLC
- 510(k) number
- K254123
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-11
- Date received
- 2025-12-19
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Yurek
- Address
- 2910 Falling Waters Blvd. Lindenhurst IL US 60046 60046
FDA Registration Numbers#
- 9680794
- 3013445787
- 1722139
- 3006891665
- 3003700453
- 3008307705
- 3045322464
- 3011689956
- 3004140833
- 3012410077
- 3015225571
- 1410248
- 3036978618
- 3001124136
- 3012809732
- 1030451
- 3002807090
- 3003895440
- 2433012
- 3043226252
- 3008537309
- 3015140199
- 3020460367
- 3012337868
- 3019807891
- 1000304305
- 3015453963
- 1220477
- 1417485
- 3004111573
- 3010934635
- 9681819
- 3002296055
- 3006174295
- 1724474
- 3008328679
- 3010405396
- 9615588
- 3015983454
- 3015620563
- 1450662
- 9610847
- 3006158088
- 3005382983
- 2030624
- 3000240707
- 3009456923
- 3010531069
- 3007829657
- 2011068
- 3013557562
- 3031233007
- 3029973819
- 3022964615
- 3008806809
- 3016938816
- 3014312726
- 3030419987
- 3012445205
- 3003512059
- 3004215921
- 3014498869
- 9611423
- 3033589330
- 1424263
- 1928237
- 3015173212
- 3008810357
- 3038356900
- 3011237770
- 1720929
- 3007392007
- 3004735647
- 1932668
- 9680306
- 3007344957
- 1018233
- 3008588205
- 9611004
Source Documents#
Other 510(k) Records For Product Code FPA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 |
| 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) | Amsino International, Inc. | 2026-05-04 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 |