510(k) · Cleared
ClearedCopilot Health Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Dec 14, 2006 as substantially equivalent to K040628 (Abbott Laboratories, 2004) after a 90-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952279 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 1 generation backK040628 Precision Link Diabetes Data Management SystemAbbott Laboratories · 2004
- This deviceK062770 Copilot Health Management SystemAbbott Diabetes Care, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK102063 Health-E-Connect SystemAlr Technologies · 2011
- Descendant · 2 generations on · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
- Descendant · cites it directly · 0 of its ownK123089 Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001Abbott Laboratories · 2013
Most influential descendants
Showing 3 of 3 · See all- K102063Health-E-Connect SystemAlr Technologies · 2011 · cites it directly1descendant
- K163664Health-e-Connect System with IDAAlr Technologies · 2017 · 2 generations on0descendants
- K123089Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001Abbott Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −1 | K040628 | Precision Link Diabetes Data Management System | Abbott Laboratories | 2004 | — |
| 0 (this device) | K062770 | Copilot Health Management System | Abbott Diabetes Care, Inc. | 2006 | — |
| +1 | K102063 | Health-E-Connect System | Alr Technologies | 2011 | — |
| +2 | K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017 | — |
| +1 | K123089 | Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001 | Abbott Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 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 |
|---|---|---|---|
| * | K040628 | Precision Link Diabetes Data Management SystemSummary page 1…Precision r Linka Diabetes Data Management SystemK040628) (cleared 3/25/2004, under Device Desc rip… | 2004 |
What descends from it? (3)
2 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102063 (Alr Technologies, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The CoPilotTM Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.
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/K062770 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062770: Copilot Health Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062770
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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