510(k) · Cleared
ClearedIglucose System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Positiveid Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 10, 2011 as substantially equivalent to K062377 (Medapps, Inc., 2007) and 1 other predicate after a 125-day review. Its family tree reaches back 9 generations to 1987. 2 later devices descend from it.
- Decided
- Nov 10, 2011
- Review
- 125 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K864318 (1987). 27 ancestors in all, the oldest K790130 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 1 generation backK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- This deviceK111932 Iglucose SystemPositiveid Corporation · 2011
- Descendant · cites it directly · 1 of its ownK130676 Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013
- Descendant · 2 generations on · 0 of its ownK132148 S HealthSamsung Electronics Co., Ltd. · 2013
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- 1 generation backK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- This deviceK111932 Iglucose SystemPositiveid Corporation · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| −1 | K062377 | Medapps Remote Patient Monitoring, Model MA 100 | Medapps, Inc. | 2007 | — |
| 0 (this device) | K111932 | Iglucose System | Positiveid Corporation | 2011 | — |
| +1 | K130676 | Ambio Remote Health Monitoring System | Arrayent Health, LLC D/B/A Ambio Health | 2013 | — |
| +2 | K132148 | S Health | Samsung Electronics Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K062377 | Medapps Remote Patient Monitoring, Model MA 100Summary page 1…ication Name: Classification: Glucose Test System 21 CFR 862.1345 Product code: NBW Class 11 Predicate Devices: 1) MedApps Remote Patient Monitoring System, K062377, Product Code: NBW 2) IDEAL LIFE Pod, K080538, Product Code: NBW, JQP Indications for Use: The iglucoseTM System collects and… | 2007 |
| * | K080538 | Ideal Life Pod (Model Ilp 0001)Summary page 1…stem 21 CFR 862.1345 Product code: NBW Class 11 Predicate Devices: 1) MedApps Remote Patient Monitoring System, K062377, Product Code: NBW 2) IDEAL LIFE Pod, K080538, Product Code: NBW, JQP Indications for Use: The iglucoseTM System collects and transmits stored data from a variety of FDA cle… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130676 | Ambio Remote Health Monitoring System | 2013 | 1 |
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 24 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K130676 (Arrayent Health, LLC D/B/A Ambio Health, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K062377.
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 iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings. The iglucose™ System does…
Read the full statement (124 words)
The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings.
The iglucose™ System does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111932: Iglucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111932
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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