510(k) · Cleared
ClearedOne Touch Profile Complete Diabetes Tracking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jun 1, 1995 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.
- Decided
- Jun 1, 1995
- Review
- 105 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
75 later devices descend from it, 2 citing it directly.
- This deviceK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- Descendant · cites it directly · 47 of its ownK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- Descendant · 2 generations on · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- Descendant · 2 generations on · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 2 generations on · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K040086Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004 · cites it directly47descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
- K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · 2 generations on40descendants
- K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on39descendants
- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| +1 | K040086 | Health Buddy with Buddylink | Health Hero Network, Inc. | 2004 | — |
| +2 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| +2 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| +2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (75)
See all 752 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, K040086 (Health Hero Network, Inc., 2004) has gone furthest, with 47 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/K950727 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950727: One Touch Profile Complete Diabetes Tracking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950727
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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