510(k) · Cleared
ClearedThe M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 19, 2002 as substantially equivalent to K993169 (Hewlett-Packard Co., 1999) after an 11-day review. Its family tree reaches back 4 generations to 1987. 98 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864318 (1987). 11 ancestors in all, the oldest K790130 (1979). 98 later devices descend from it, 10 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 deviceK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- Descendant · cites it directly · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- Descendant · cites it directly · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- Descendant · cites it directly · 59 of its ownK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- Descendant · 2 generations on · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
- Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K031840Carematix Wellness SystemCarematix, Inc. · 2003 · cites it directly90descendants
- K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · cites it directly86descendants
- K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004 · cites it directly59descendants
- K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · 2 generations on45descendants
- K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
View 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) | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| +1 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| +1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| +1 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| +2 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
| +2 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 14 | 0 |
| 2010 | 9 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 13 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810ASummary page 1…antially equivalent to the previously cleared Modification of Physiological Signal Transmitter & Receiver pursuant to K993 169 (September 22, 1999). Modifications The primary modification is a change to add the functionality of glucose… | 1999 |
What descends from it? (98)
See all 9810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031840 | Carematix Wellness System | 2003 | 90 |
| K040966 | Modification to Carematix Wellness System | 2004 | 86 |
| K041816 | RTX3320PSTN Wireless Telehealth Gateway | 2004 | 59 |
| K080798 | Intel Health Guide, Model: PHS6000 | 2008 | 25 |
| K051470 | Remote Care Management Systems (RCMS) | 2005 | 21 |
| K062304 | DLM112 Daylink Monitor | 2006 | 8 |
| K062662 | Telemedicine System Model VMS-01 | 2006 | 2 |
| K062127 | MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp) | 2006 | 2 |
| K061502 | MEDIC4ALL Telemedicine System VMS-01 | 2006 | 2 |
| K103796 | Telemedcare Health Monitor | 2011 | 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 15 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K031840 (Carematix, Inc., 2003) has gone furthest, with 90 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.
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 M3810A Philips TeleMonitoring System with M3812B TeleStation 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 (134 words)
The M3810A Philips TeleMonitoring System with M3812B TeleStation 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 to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinica 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/K023749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023749
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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