510(k) · Cleared
ClearedMallyaD injection pen adapter (MallyaD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocorp Production · QOG Injection Data Capture Device
Cleared on Mar 27, 2025 as substantially equivalent to K231820 (Biocorp Production, 2024) after a 30-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it.
- Decided
- Mar 27, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- QOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010362 (2001). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 6 generations between
- 3 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 2 generations backK222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022
- 1 generation backK231820 SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production · 2024
- This deviceK250555 MallyaD injection pen adapter (MallyaD)Biocorp Production · 2025
- Descendant · cites it directly · 0 of its ownK251500 MallyaG Injection Pen Adapter (MallyaG)Biocorp Production · 2025
Show all 10 generations
- Root · 10 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 9 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 8 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 7 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 6 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 5 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 4 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 3 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 2 generations backK222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production · 2022
- 1 generation backK231820 SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production · 2024
- This deviceK250555 MallyaD injection pen adapter (MallyaD)Biocorp Production · 2025
Most influential descendants
Showing 1 of 1 · See all- K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −9 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −8 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −7 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −6 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −5 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −4 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −3 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −2 | K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022 | — |
| −1 | K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | 2024 | — |
| 0 (this device) | K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | 2025 | — |
| +1 | K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K222689 Mallya Injection Pen Adapter (Mallya® for…score 12.6 · 8 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 |
|---|---|---|---|
| * | K231820 | SoloSmart Injection Pen Adapter (SoloSmart®)Summary page 5…on Name: 21 CFR §880.5860 Piston Syringe Product Code: QOG Class: II 3 PREDICATE DEVICE K231820, Biocorp Production, SoloSmart Injection Pen Adapter (SoloSmart®). 4 SUBSTANTIAL EQUIVALENCE The MallyaD Injection Pen Adapter d… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | 2025 | 0 |
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 6 companies; a new generation was cleared every 1.3 years on median.
- 12 of the 18 ancestors have a recall of any class.
- Of its descendants, K251500 (Biocorp Production, 2025) has gone furthest, with 0 descendants of its own.
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 MallyaD Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are:
- insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch)
- insulin aspart molecule (Fiasp FlexTouch)
- insulin degludec and liraglutide molecules (Xultophy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250555: MallyaD injection pen adapter (MallyaD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250555
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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