# K100553: Blood Pressure Meter Model CH-101

- Pathway: 510(k) (Traditional)
- Applicant: Citizen Systems Japan Co., Ltd.
- Decided: May 25, 2010 after 88 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112273: Accumed Upper Arm Automatic Blood Pressure Monitor (2011), 0 descendants of its own

## Indications for use
Model CH-101 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Source page: https://510kreport.com/device/K100553
Methodology: https://510kreport.com/methodology