# K120470: MIPAL

- Pathway: 510(k) (Traditional)
- Applicant: Watermark Medical
- Decided: Jun 8, 2012 after 113 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040799 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061087: Genesis Otc Monitor, Honeywell Hommed, LLC (2006) Summary page 1.

## Indications for use
MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age. SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

Source page: https://510kreport.com/device/K120470
Methodology: https://510kreport.com/methodology