# K082626: PAM 3000

- Pathway: 510(k) (Traditional)
- Applicant: Wireless 2000 RF & Uwb Technologies, Ltd.
- Decided: Jan 16, 2009 after 129 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830295 (1983). 17 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070375: Earlysense ES-16 System, Earlysense, Ltd. (2007) Summary page 1.
- K052446: LG1 Intelligent Medical Vigilance System, Hoana Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K092062: Everon 1.0 (2010), 10 descendants of its own
- K202464: Vital Sign Monitoring Sensor (Model :XK300) (2021), 9 descendants of its own
- K120465: Earlysense (Everon) System (2012), 9 descendants of its own
- K131379: Earlysense (2013), 7 descendants of its own
- K133661: Chair Sensing Unit for Earlysense System (2014), 6 descendants of its own

## Indications for use
The PAAvTm3000 system is intended to measure heart rate and respiration rate m adult patients, m a general care hospital environment including, nursing homes The system momtors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion

Source page: https://510kreport.com/device/K082626
Methodology: https://510kreport.com/methodology