# K103058: Multifunction Keito

- Pathway: 510(k) (Traditional)
- Applicant: Aguiflai Iberica S.L.
- Decided: Nov 10, 2011 after 392 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K930599 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811146: Vita-Stat Model 8000-C, Vita-Stat (1981) Summary page 4.
- K984083: Multifunction Keito K5, Bumedco Intl., Inc. (2000) Summary page 2.
- K014009: Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale, Tanita Corp. of America (2002) Summary page 4.
- K011652: Body Fat Analyzer, Model HBF-306, Omron Healthcare, Inc. (2001) Summary page 4.

## Indications for use
The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, height, estimation of body fat index, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.

Source page: https://510kreport.com/device/K103058
Methodology: https://510kreport.com/methodology