510(k) · Cleared
ClearedCamit Diabetes Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CGA Glucose Oxidase, Glucose
Cleared on Sep 5, 2000 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Sep 5, 2000
- Review
- 75 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- Descendant · cites it directly · 9 of its ownK080227 Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
- Descendant · 2 generations on · 8 of its ownK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
- Descendant · 3 generations on · 5 of its ownK162532 WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK190013 WellDoc BlueStarWelldoc, Inc. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K080227Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008 · cites it directly9descendants
- K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010 · 2 generations on8descendants
- K070941Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007 · cites it directly8descendants
- K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017 · 3 generations on5descendants
- K190013WellDoc BlueStarWelldoc, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| +1 | K080227 | Accu-Chek 360 Diabetes Management System | Roche Diagnostics Corp. | 2008 | — |
| +2 | K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | Welldoc, Inc. | 2010 | — |
| +1 | K070941 | Clever Chek Health Care System Software, Version 1.0 | Taidoc Technology Corporation | 2007 | — |
| +3 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017 | — |
| +4 | K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K080227 (Roche Diagnostics Corp., 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K001907 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001907: Camit Diabetes Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001907
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026