510(k) · Cleared
ClearedM3810A Philips Telemonitoring System with Edevice BRIDGED130
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifeline Systems, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 1, 2010 as substantially equivalent to K993169 (Hewlett-Packard Co., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Dec 1, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864318 (1987). 15 ancestors in all, the oldest K790130 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 3 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 2 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 1 generation backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- This deviceK103214 M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK141706 Ecare Coordinator (Ecc)Visicu, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK171029 eCareCoordinatorVisicu, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK222398 Care Team PortalVivify Health, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −3 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −2 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −1 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| 0 (this device) | K103214 | M3810A Philips Telemonitoring System with Edevice BRIDGED130 | Lifeline Systems, Inc. | 2010 | — |
| +1 | K141706 | Ecare Coordinator (Ecc) | Visicu, Inc. | 2014 | 2 |
| +2 | K171029 | eCareCoordinator | Visicu, Inc. | 2017 | — |
| +3 | K222398 | Care Team Portal | Vivify Health, Inc. | 2023 | — |
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 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810ASummary page 1…substantially equivalent to the previously cleared Modification of Physiological Signal Transmitter & Receiver pursuant to K993169 (September 22, 1999). Confidential Page 55… | 1999 |
| * | K101242 | Genesis DM Model: 6053000A1Summary page 2…server. This device is substantially equivalent to the previous cleared Honeywell HomMedtGenesis DM Remote Patient Care Monitor K101242, the difference between the two devices is that the eDevice BridgeD1l30 is an external communication… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141706 | Ecare Coordinator (Ecc) | 2014 | 2 |
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 23 years and passes through 5 companies; a new generation was cleared every 9.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K141706 (Visicu, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K993169.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The M38IOA Philips TeleMonitoring System with eDevice Bridgefll30 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day…
Read the full statement (137 words)
The M38IOA Philips TeleMonitoring System with eDevice Bridgefll30 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, isehemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post miyocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103214: M3810A Philips Telemonitoring System with Edevice BRIDGED130.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103214
Report an extraction error
Are you the manufacturer?
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