# K041674: The M3810A Philips Telemonitoring System with M3814A SPO2 Unit

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jul 19, 2004 after 28 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864318 (1987). 11 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992478: Physiological Signal Transmitter and Receiver, Model 3810A, Hewlett-Packard, Healthcare Solutions Group (1999) Summary page 1.

## Most influential descendants
- K063612: Modification to Health Buddy Appliance (2006), 30 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 descendants of its own
- K101178: Modification to Intel Health Guide PHS6000 (2010), 11 descendants of its own

## Recalls of this device
- Sep 11, 2008 · Not classified · Z-0100-2009: Multiprint report may contain incorrect vital data for patients
- Jul 22, 2008 · Not classified · Z-2369-2008: Software: If Weight Limits edited, values will return to default values that were deleted

## Indications for use
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.

Source page: https://510kreport.com/device/K041674
Methodology: https://510kreport.com/methodology