510(k) · Cleared
Recalled · 2008The M3810A Philips Telemonitoring System with M3814A SPO2 Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DQA Oximeter
Cleared on Jul 19, 2004 as substantially equivalent to K992478 (Hewlett-Packard, Healthcare Solutions Group, 1999) after a 28-day review. Its family tree reaches back 4 generations to 1987. 34 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 19, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864318 (1987). 11 ancestors in all, the oldest K790130 (1979). 34 later devices descend from it, 3 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 backK992478 Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard, Healthcare Solutions Group · 1999
- This deviceK041674 The M3810A Philips Telemonitoring System with M3814A SPO2 UnitPhilips Medical Systems · 2004
- Descendant · cites it directly · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 2 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · cites it directly30descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 2 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 3 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 3 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 3 generations on11descendants
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 | K992478 | Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard, Healthcare Solutions Group | 1999 | — |
| 0 (this device) | K041674 | The M3810A Philips Telemonitoring System with M3814A SPO2 Unit | Philips Medical Systems | 2004 | — |
| +1 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +3 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K992478 | Physiological Signal Transmitter and Receiver, Model 3810ASummary page 1…vices The modified device is substantially equivalent to the previously cleared Physiological Signal Transmitter & Receiver pursuant to K992478 (October 15, 1999). Modifications The primary modification is a change to add the function… | 1999 |
What descends from it? (34)
See all 343 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2008 | Not classified | Z-0100-2009 | Software design | Multiprint report may contain incorrect vital data for patients |
| Jul 22, 2008 | Not classified | Z-2369-2008 | Software design | Software: If Weight Limits edited, values will return to default values that were deleted |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K063612 (Health Hero Network, Inc., 2006) has gone furthest, with 30 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 (103 words)
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 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/K041674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041674: The M3810A Philips Telemonitoring System with M3814A SPO2 Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041674
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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