Accu-Chek Ultraflex Infusion Set
FDA 510(k) K070189 · Disetronic Medical Systems AG
510(k) numberK070189
Submission
- Device name
- Accu-Chek Ultraflex Infusion Set
- Applicant
- Disetronic Medical Systems AG
Indianapolis, IN, US - Received
- January 22, 2007
- Decision date
- February 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K100704 | Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion DeviceFRN · Special | 05/14/2010SE |
| K063146 | Accu-Chek LinkassistKZH · Traditional | 11/27/2006SE |
| K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…LZG · Traditional | 06/15/2006SE |
| K042887 | Accu-Chek SpiritLZG · Traditional | 03/18/2005SE |
| K043000 | Modification to D-TronplusLZG · Special | 12/01/2004SE |
| K033892 | Ultraflex Infusion SetFPA · Traditional | 03/09/2004SE |
| K023471 | Disetronic H-Tronplus Insulin Infusion PumpLZG · Special | 10/29/2002SE |
| K022831 | Modification to Disetronic D-Tronplus Insulin Infusion PumpLZG · Special | 09/11/2002SE |
| K021725 | Disetronic D-Tron Insulin Infusion PumpLZG · Special | 08/02/2002SE |
| K013782 | Disetronic Penfine Insulin Injection Pen NeedleFMI · Traditional | 11/20/2001SE |
Questions and answers
When was Accu-Chek Ultraflex Infusion Set cleared by the FDA?
Accu-Chek Ultraflex Infusion Set (K070189) received a 510(k) decision of Substantially Equivalent on February 21, 2007, 30 days after the submission was received.
What is the product code of K070189?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.