510(k) · Cleared
ClearedE-San Bluetooth Cradle
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 Dec 7, 2005 as substantially equivalent to K041816 (Rtx Healthcare A/S, 2004) after a 103-day review. Its family tree reaches back 6 generations to 1987. 25 later devices descend from it.
- Decided
- Dec 7, 2005
- Review
- 103 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864318 (1987). 13 ancestors in all, the oldest K790130 (1979). 25 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 4 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 3 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 2 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 1 generation backK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- This deviceK052343 E-San Bluetooth CradleE-San Limited · 2005
- Descendant · cites it directly · 24 of its ownK061328 Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006
- Descendant · 2 generations on · 20 of its ownK062377 Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007
- Descendant · 3 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 4 generations on · 4 of its ownK124000 Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013
- Descendant · 3 generations on · 4 of its ownK112559 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K061328Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006 · cites it directly24descendants
- K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc. · 2007 · 2 generations on20descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 3 generations on12descendants
- K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect · 2013 · 4 generations on4descendants
- K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2011 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −5 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −4 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −3 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −2 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −1 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| 0 (this device) | K052343 | E-San Bluetooth Cradle | E-San Limited | 2005 | — |
| +1 | K061328 | Think Positive Diabetes Management System (T+Diabetes System) | E-San Limited | 2006 | — |
| +2 | K062377 | Medapps Remote Patient Monitoring, Model MA 100 | Medapps, Inc. | 2007 | — |
| +3 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +4 | K124000 | Medapps 2.0 - Remote Patient Monitoring System | Medapps Inc., Dba Alere Connect | 2013 | — |
| +3 | K112559 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2011 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041816 | RTX3320PSTN Wireless Telehealth Gateway | 2004 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061328 | Think Positive Diabetes Management System (T+Diabetes System) | 2006 | 24 |
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 18 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K061328 (E-San Limited, 2006) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K041816.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052343: E-San Bluetooth Cradle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052343
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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