# K093102: Ambulatory Blood Pressure Monitor, Models FB-270 and DS-270

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Jun 3, 2010 after 245 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: 1 generation back to K913595 (1992). 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)
- K913595: DS-240 Ambulatory Blood Pressure Monitoring System, Koven and Assoc., Inc. (1992) Summary page 1.
- K992808: A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure, A&D Medical Div. (1999) Summary page 1.

## Indications for use
FB-270/DS-270 is a portable blood pressure monitor for non-invasive blood pressure measurement, monitoring intraday variance of blood pressure in dally life. They measure systolic and diastolic blood pressure and heart rate, at set interval within 24/48 hours c;r manually, and store the data to SD card (memory card). The collected data can ensure the change in the day of the blood pressure in the personal computer using CD-ROM for exclusive setup. Physicians at medical institutions will check the data on personal computer for analysis of - hypertensive and hypoter}sive diseases.

Source page: https://510kreport.com/device/K093102
Methodology: https://510kreport.com/methodology