510(k) · Cleared
ClearedAccu-Chek 360 Diabetes Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · MRZ Accessories, Pump, Infusion
Cleared on May 15, 2008 as substantially equivalent to K001907 (Roche Diagnostics Corp., 2000) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001907 (2000). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- This deviceK080227 Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
- Descendant · cites it directly · 8 of its ownK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK162532 WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK190013 WellDoc BlueStarWelldoc, Inc. · 2019
- Descendant · 4 generations on · 3 of its ownK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · 5 generations on · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010 · cites it directly8descendants
- K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017 · 2 generations on5descendants
- K190013WellDoc BlueStarWelldoc, Inc. · 2019 · 3 generations on4descendants
- K193654BlueStar RxWelldoc, Inc. · 2020 · 4 generations on3descendants
- K203434BlueStar RxWelldoc, Inc. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K080227 | Accu-Chek 360 Diabetes Management System | Roche Diagnostics Corp. | 2008 | — |
| +1 | K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | Welldoc, Inc. | 2010 | — |
| +2 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017 | — |
| +3 | K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019 | — |
| +4 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +5 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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), 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K001907 | Camit Diabetes Management Software | 2000 |
| * | K062395 | Accu-Chek Smart PixSummary page 1…Diabetes Device(s) Management System to the current legally marketed Camit Diabetes Management Software (KOO 1907) and Smart Pix Device Reader (K062395). Device Software accessory to ACCU-CHEK®brand meters and/or Description Disetronic/ACCU-CHEK insulin infusion… | 2007 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | 2010 | 8 |
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?
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACCU-CHEK ® 3600 Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without diabetes related information, which can be shown in report and graphical format. This device is indicated for professional use and over-the-counter sale.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080227 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080227: Accu-Chek 360 Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080227
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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