OneTouch Via On-Demand Insulin Delivery System
FDA 510(k) clearance K163357 · decided 2017-06-07
Clearance details
- K-number
- K163357
- Device name
- OneTouch Via On-Demand Insulin Delivery System
- Applicant
- Lifescan Europe, A Division of Cilag GmbH
- Decision
- Substantially Equivalent
- Date received
- 2016-11-30
- Decision date
- 2017-06-07
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- OPP
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Zug, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CeQur Simplicity™ On-Demand Insulin Delivery System (K252757) | Cequr SA | 2026-04-10 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K243273) | Cequr SA | 2024-11-13 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K233447) | Cequr SA | 2024-01-18 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH (K111924) | Calibra Medical, Inc. | 2012-04-10 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (K100947) | Calibra Medical, Inc. | 2010-06-28 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (K093065) | Calibra Medical, Inc. | 2010-01-20 |
Recalls involving this device
No recalls on record reference this clearance.