Accu-Chek Ultraflex Infusion Set
FDA 510(k) K122686 · Roche Diabetes Care AG
510(k) numberK122686
Submission
- Device name
- Accu-Chek Ultraflex Infusion Set
- Applicant
- Roche Diabetes Care AG
Burgdorf, CH - Received
- September 4, 2012
- Decision date
- November 16, 2012
- 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
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 |
|---|---|---|
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK · Traditional | 11/13/2023SE |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK · Traditional | 11/13/2023SE |
| K213134 | Accu-Chek Solo micropump system with interoperable technologyQFG · Traditional | 08/10/2023SE |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemNBW · Traditional | 08/10/2023SE |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK · Traditional | 05/19/2022SE |
| K203711 | IWL2020 Blood Glucose Monitoring SystemNBW · Traditional | 05/06/2022SE |
| K220608 | Accu-Chek FastClix Blood Lancing SystemQRL · Traditional | 04/29/2022SE |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK · Traditional | 04/05/2022SE |
| K214022 | Accu-Chek Softclix Blood Lancing SystemQRL · Traditional | 02/17/2022SE |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW · Special | 12/13/2018SE |
Questions and answers
When was Accu-Chek Ultraflex Infusion Set cleared by the FDA?
Accu-Chek Ultraflex Infusion Set (K122686) received a 510(k) decision of Substantially Equivalent on November 16, 2012, 73 days after the submission was received.
What is the product code of K122686?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.