510(k) · Cleared
ClearedSmartPilot YpsoMate NS-A2.25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ypsomed AG · QOG Injection Data Capture Device
Cleared on Aug 28, 2025 as substantially equivalent to K222689 (Biocorp Production, 2022) after a 252-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Aug 28, 2025
- Review
- 252 days
- Class
- Class II
- Product code
- QOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010362 (2001). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations between
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022
- This deviceK243901 SmartPilot YpsoMate NS-A2.25Ypsomed AG · 2025
Show all 9 generations
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 8 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 7 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 6 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 5 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 4 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022
- This deviceK243901 SmartPilot YpsoMate NS-A2.25Ypsomed AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −8 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −7 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −6 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −5 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −3 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −2 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −1 | K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022 | — |
| 0 (this device) | K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 QOG? 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 QOG device
- #1 K250555 MallyaD injection pen adapter (MallyaD)score 14.8 · 10 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 |
|---|---|---|---|
| * | K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®)Summary page 5…ata Capture Device Classification Name: Piston Syringe (21 CFR 880.5860) Regulatory Class: II Product Code: QOG III. PREDICATE DEVICE Mally Injection Pen Adapter, K222689 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2022 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K222689.
How does its category compare?
All QOG devicesQOG Injection Data Capture Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QOG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOG
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOG
No recall names QOG since 2007.
Adverse event reports per year · QOG
1in 2022
MAUDE reports naming product code QOG, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 30 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243901: SmartPilot YpsoMate NS-A2.25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243901
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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