510(k) · Cleared
ClearedTempo Smart Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli Lilly and Company · QOG Injection Data Capture Device
Cleared on Sep 16, 2022 as substantially equivalent to K160629 (Companion Medical, Inc., 2016) after a 427-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it.
- Decided
- Sep 16, 2022
- Review
- 427 days
- Class
- Class II
- Product code
- QOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010362 (2001). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 7 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 6 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 5 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 4 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 3 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 2 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 1 generation backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- This deviceK212217 Tempo Smart ButtonEli Lilly and Company · 2022
- Descendant · cites it directly · 0 of its ownK241803 INSULCLOCK® v2.0 PROInsulcloud S.L. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241803INSULCLOCK® v2.0 PROInsulcloud S.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −7 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −6 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −5 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −4 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −2 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −1 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| 0 (this device) | K212217 | Tempo Smart Button | Eli Lilly and Company | 2022 | — |
| +1 | K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K160629 | InPenSummary page 4…Device Regulation 21 CFR §880.5860 Piston Syringe Product Codes: QOG, OCN Class: II III. Predicate Device InPen System (K160629) IV. Device Description The Tempo Smart Button is a reusable data transmitter that detects and stores insulin dose- relat… | 2016 |
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 |
|---|---|---|---|
| K241803 | INSULCLOCK® v2.0 PRO | 2024 | 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 21 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 16 ancestors have a recall of any class.
- Of its descendants, K241803 (Insulcloud S.L., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K160629.
How does its category compare?
All QOG devicesQOG Injection Data Capture Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App).
The Tempo Smart Button is indicated for single-patient use by patients 18 years or older who are:
» diagnosed with type 1 or type 2 diabetes mellitus,
* using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev® Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL],
* using a compatible application (App).
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/K212217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212217: Tempo Smart Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212217
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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