510(k) · Cleared
ClearedCeQur Simplicity™ On-Demand Insulin Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cequr SA · OPP Pump, Infusion, Insulin Bolus
Cleared on Apr 10, 2026 as substantially equivalent to K243273 (Cequr SA, 2024) and 2 other predicates after a 224-day review. Its family tree reaches back 8 generations to 2003.
- Decided
- Apr 10, 2026
- Review
- 224 days
- Class
- Class II
- Product code
- OPP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K031373 (2003). 10 ancestors in all, the oldest K010359 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
- 7 generations backK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
- 6 generations backK093065 Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010
- 5 generations backK100947 Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010
- 4 generations backK111924 Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012
- 3 generations backK163357 OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017
- 2 generations backK233447 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024
- 1 generation backK243273 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024
- This deviceK252757 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| −7 | K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | 2005 | — |
| −6 | K093065 | Finesse Personal Insulin Delivery Patch, Model FG-2000 | Calibra Medical, Inc. | 2010 | — |
| −5 | K100947 | Finesse Personal Insulin Delivery Patch, Model FG 2000 | Calibra Medical, Inc. | 2010 | — |
| −4 | K111924 | Finesse Personal Insulin Delivery Patch | Calibra Medical, Inc. | 2012 | — |
| −3 | K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | 2017 | — |
| −2 | K233447 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024 | — |
| −1 | K243273 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K243273 | CeQur Simplicity™ On-Demand Insulin Delivery SystemSummary page 5…5725 Product Code(s) OPP, LZG | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K243273 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K233447 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K163357 O… | 2024 |
| * | K233447 | CeQur Simplicity™ On-Demand Insulin Delivery SystemSummary page 5…ces 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K243273 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K233447 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K163357 OneTouch Via On-Demand Insulin Delivery System OPP Device Descrip… | 2024 |
| * | K163357 | OneTouch Via On-Demand Insulin Delivery SystemSummary page 5…y Predicate is listed first) Product Code K243273 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K233447 CeQur Simplicity™ On-Demand Insulin Delivery System OPP K163357 OneTouch Via On-Demand Insulin Delivery System OPP Device Description Summary 21 CFR 807.92(a)(4) The CeQur Simplicity™ On-Deman… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All OPP devicesOPP Pump, Infusion, Insulin Bolus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 CeQur Simplicity™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252757: CeQur Simplicity™ 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/K252757
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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