510(k) · Cleared
ClearedHealth-E-Connect System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alr Technologies · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 11, 2011 as substantially equivalent to K062770 (Abbott Diabetes Care, Inc., 2006) and 1 other predicate after a 445-day review. Its family tree reaches back 11 generations to 1987. 1 of the 75 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 11, 2011
- Review
- 445 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K864318 (1987). 73 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 75 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK090801 Electronic House CallExpress MD Solutions, LLC · 2009
- This deviceK102063 Health-E-Connect SystemAlr Technologies · 2011
- Descendant · cites it directly · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 3 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 2 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 1 generation backK090801 Electronic House CallExpress MD Solutions, LLC · 2009
- This deviceK102063 Health-E-Connect SystemAlr Technologies · 2011
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes4 generations back · 2002
Most influential descendants
Showing 1 of 1 · See all- K163664Health-e-Connect System with IDAAlr Technologies · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −3 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −2 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −1 | K090801 | Electronic House Call | Express MD Solutions, LLC | 2009 | — |
| 0 (this device) | K102063 | Health-E-Connect System | Alr Technologies | 2011 | — |
| +1 | K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 1 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K062770 | Copilot Health Management SystemSummary page 1…Calculator/Data Processing Module for Clinical Use JQP - 862.2 100, Class -I Predicate Device: K062770 Copilot Health Management System Abbott Dia… | 2006 |
| * | K090801 | Electronic House CallSummary page 1…Copilot Health Management System Abbott Diabetes Care Inc. K090801 Electronic House Call System Express MD Sol… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163664 | Health-e-Connect System with IDA | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 73 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163664 (Alr Technologies, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062770.
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. 2011, this device’s year, is highlighted.
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 Health-c-Connect System is intended for use in the home and clinical settings by people with diabetes and healthcare providers as an aid in the review, analysis and evaluation of historical glucose test results and associated usage data 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/K102063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102063: Health-E-Connect System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102063
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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