510(k) · Cleared
ClearedThink Positive Diabetes Management System (T+Diabetes System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-San Limited · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 13, 2006 as substantially equivalent to K052343 (E-San Limited, 2005) after a 32-day review. Its family tree reaches back 7 generations to 1987. 24 later devices descend from it.
- Decided
- Jun 13, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K864318 (1987). 14 ancestors in all, the oldest K790130 (1979). 24 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 3 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 2 generations backK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- 1 generation backK052343 E-San Bluetooth CradleE-San Limited · 2005
- This deviceK061328 Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006
- Descendant · cites it directly · 20 of its ownK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 4 of its ownK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · 2 generations on · 4 of its ownK112559 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007 · cites it directly20descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 2 generations on12descendants
- K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013 · 3 generations on4descendants
- K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011 · 2 generations on4descendants
- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −3 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −2 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| −1 | K052343 | E-San Bluetooth Cradle | E-San Limited | 2005 | — |
| 0 (this device) | K061328 | Think Positive Diabetes Management System (T+Diabetes System) | E-San Limited | 2006 | — |
| +1 | K062377 | Medapps Remote Patient Monitoring, Model MA 100 | Medapps, Inc. | 2007 | — |
| +2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +2 | K112559 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2011 | — |
| +2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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 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 |
|---|---|---|---|
| * | K052343 | E-San Bluetooth CradleSummary page 1…Washington, DC 20006 A. Legally Marketed Predicate Device The modified t+ Diabetes System is substantially equivalent to the previous version of the device (K052343). B. Device Description The e-San Bluetooth Cradle is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System… | 2005 |
What descends from it? (24)
See all 244 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 19 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K062377 (Medapps, Inc., 2007) has gone furthest, with 20 descendants 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 e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230.
The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone.
The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061328: Think Positive Diabetes Management System (T+Diabetes System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061328
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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