Ez-Connect
FDA 510(k) K061771 · Vidacare Corporation
510(k) numberK061771
Submission
- Device name
- Ez-Connect
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- June 23, 2006
- Decision date
- July 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142377 | The OnControl Bone Marrow Biopsy System by VidacareKNW · Traditional | 12/17/2014SE |
| K141117 | Ez-Io Intraosseous Infusion SystemFMI · Traditional | 07/08/2014SE |
| K132583 | Ez-Io Intraosseous Infusion SystemFMI · Traditional | 02/11/2014SE |
| K120661 | The T.A.L.O.N. Intraossous Infusion System by VidacreFMI · Traditional | 06/03/2012SE |
| K113872 | The Oncontrol Bone Access and Bone Biopsy System by VidacareKNW · Traditional | 03/08/2012SE |
| K101026 | Powered Pd-Io Infusion System, Ez-Io Humeral Head, Powered Ph-IoFMI · Traditional | 07/27/2010SE |
| K091140 | Ez-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-IoFMI · Traditional | 10/14/2009SE |
| K081713 | Vertebral Access System by VidacareMOQ · Traditional | 11/21/2008SE |
| K072045 | Oncontrol Bone Marrow Biopsy SystemKNW · Traditional | 10/22/2007SE |
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | 05/21/2007SE |
Questions and answers
When was Ez-Connect cleared by the FDA?
Ez-Connect (K061771) received a 510(k) decision of Substantially Equivalent on July 10, 2006, 17 days after the submission was received.
What is the product code of K061771?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.