# K984083: Multifunction Keito K5

- Pathway: 510(k) (Traditional)
- Applicant: Bumedco Intl., Inc.
- Decided: Jan 18, 2000 after 428 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Omron Portable Wrist Blood Pressure Kit, Model HEM-608: named in the summary without a submission number
- (no number) Vita-Stat Model 8000-C: named in the summary without a submission number

## Most influential descendants
- K103058: Multifunction Keito (2011), 0 descendants of its own

## Indications for use
The Multifunction KEITO K35 is intended to be used by adults in order to measure height, weight, systolic and diastolic blood pressures, and to calculate pulse rate.

Source page: https://510kreport.com/device/K984083
Methodology: https://510kreport.com/methodology