510(k) · Cleared
ClearedOneTouch Via On-Demand Insulin Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan Europe, A Division of Cilag GmbH · OPP Pump, Infusion, Insulin Bolus
Cleared on Jun 7, 2017 as substantially equivalent to K111924 (Calibra Medical, Inc., 2012) after a 189-day review. Its family tree reaches back 5 generations to 2003. 3 later devices descend from it.
- Decided
- Jun 7, 2017
- Review
- 189 days
- Class
- Class II
- Product code
- OPP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K031373 (2003). 7 ancestors in all, the oldest K010359 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
- 4 generations backK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
- 3 generations backK093065 Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010
- 2 generations backK100947 Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010
- 1 generation backK111924 Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012
- This deviceK163357 OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017
- Descendant · cites it directly · 2 of its ownK233447 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024
- Descendant · cites it directly · 1 of its ownK243273 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024
- Descendant · cites it directly · 0 of its ownK252757 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2026
Most influential descendants
Showing 3 of 3 · See all- K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024 · cites it directly2descendants
- K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024 · cites it directly1descendant
- K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| −4 | K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | 2005 | — |
| −3 | K093065 | Finesse Personal Insulin Delivery Patch, Model FG-2000 | Calibra Medical, Inc. | 2010 | — |
| −2 | K100947 | Finesse Personal Insulin Delivery Patch, Model FG 2000 | Calibra Medical, Inc. | 2010 | — |
| −1 | K111924 | Finesse Personal Insulin Delivery Patch | Calibra Medical, Inc. | 2012 | — |
| 0 (this device) | K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | 2017 | — |
| +1 | K233447 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024 | — |
| +1 | K243273 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024 | — |
| +1 | K252757 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OPP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OPP device
- #1 K233447 CeQur Simplicity™ On-Demand Insulin Delivery…score 14.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111924 | Finesse Personal Insulin Delivery PatchSummary page 4…ary); LZG (secondary) 21 CFR 880.5725 Class II 80 - General Hospital Legally marketed K111924 FINESSE™ Personal Insulin Delivery System predicate device: Predicate device Infusion Pump classification:… | 2012 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K233447 (Cequr SA, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OPP devicesOPP Pump, Infusion, Insulin Bolus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OPP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OPP
Too few OPP 510(k)s in any year since 2007 to give a median.
Recalls per year · OPP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OPP
1in 2025
MAUDE reports naming product code OPP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 22 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163357: OneTouch Via On-Demand Insulin Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026