510(k) · Cleared
ClearedHealthbuddy with Device Connect [Glucose Meter]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Hero Network, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Nov 23, 1999 after a 64-day review. The FDA summary names its predicate without a number. 48 later devices descend from it.
- Decided
- Nov 23, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 9 citing it directly.
- This deviceK993128 Healthbuddy with Device Connect [Glucose Meter]Health Hero Network, Inc. · 1999
- Descendant · cites it directly · 47 of its ownK040086 Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004
- Descendant · cites it directly · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- Descendant · cites it directly · 39 of its ownK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · cites it directly · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K040086Health Buddy with BuddylinkHealth Hero Network, Inc. · 2004 · cites it directly47descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · cites it directly45descendants
- K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · cites it directly40descendants
- K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly39descendants
- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993128 | Healthbuddy with Device Connect [Glucose Meter] | Health Hero Network, Inc. | 1999 | — |
| +1 | K040086 | Health Buddy with Buddylink | Health Hero Network, Inc. | 2004 | — |
| +1 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| +1 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| +1 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +1 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 8 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | — | LifeScan ONE TOUCH Profile Diabetes Tracking System Named without a submission number | |
| * | — | LifeScan IN TOUCH Diabetes Management Software Named without a submission number |
What descends from it? (48)
See all 489 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040086 | Health Buddy with Buddylink | 2004 | 47 |
| K042273 | Modification to Health Buddy with Device Connectivity | 2004 | 45 |
| K050567 | Health Buddy Appliance | 2005 | 40 |
| K060843 | Modification to Health Buddy Appliance | 2006 | 39 |
| K063612 | Modification to Health Buddy Appliance | 2006 | 30 |
| K090801 | Electronic House Call | 2009 | 3 |
| K070543 | Modification to Health Buddy Appliance | 2007 | 2 |
| K080091 | Modification to:Health Buddy Appliance | 2008 | 1 |
| K091021 | Modification to Medicompass Connect | 2009 | 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?
- 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 | — |
What is it indicated for?
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose data to healthcare professionals to help support effective management of diabetes patients.
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/K993128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993128: Healthbuddy with Device Connect [Glucose Meter].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993128
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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