510(k) · Cleared
ClearedSoloSmart Injection Pen Adapter (SoloSmart®)
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 Jan 12, 2024 as substantially equivalent to K222689 (Biocorp Production, 2022) after a 205-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 12, 2024
- Review
- 205 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. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK231820 SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production · 2024
- Descendant · cites it directly · 1 of its ownK250555 MallyaD injection pen adapter (MallyaD)Biocorp Production · 2025
- Descendant · 2 generations on · 0 of its ownK251500 MallyaG Injection Pen Adapter (MallyaG)Biocorp Production · 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 deviceK231820 SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | 2024 | — |
| +1 | K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | 2025 | — |
| +2 | 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 | 2 | 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 4…Piston Syringe 21 CFR 880.5860 Product Code: QOG 6. Predicate Device: K222689, Biocorp Production, Mallya Injection Pen Adapter 7. Applicant: Biocorp Production… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250555 | MallyaD injection pen adapter (MallyaD) | 2025 | 1 |
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 6 companies; a new generation was cleared every 1.3 years on median.
- 12 of the 17 ancestors have a recall of any class.
- Of its descendants, K250555 (Biocorp Production, 2025) has gone furthest, with 1 descendant of its own.
- 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. 2024, 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 SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors. The following Injection pens are compatible: DEVICE MODEL NAME | INSULIN BRAND NAME | MOLECULE NAME | MOLECULE CONCENTRATION | Lantus | | 100 IU/mL |_________________________| GLARGINE |_____________________________ | Toujeo | | 300 IU/mL SoloSmart…
Read the full statement (95 words)
The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
The following Injection pens are compatible:
DEVICE MODEL NAME | INSULIN BRAND NAME | MOLECULE NAME | MOLECULE CONCENTRATION
| Lantus | | 100 IU/mL
|_________________________| GLARGINE |_____________________________
| Toujeo | | 300 IU/mL
SoloSmart |_________________________|____________________|_____________________________
designed for | Admelog | LISPRO | 100 IU/mL
Solostar® SANOFI |_________________________|____________________|_____________________________
Injection pen | Apidra | GLULISINE | 100 IU/mL
|_________________________|____________________|_____________________________
| Soliqua 100/33 | GLARGINE AND | 100 IU/mL
| | LIXISENATIDE | +33mcg/mL
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231820: SoloSmart Injection Pen Adapter (SoloSmart®).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231820
Report an extraction error
Are you the manufacturer?
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