# K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Co., Ltd.
- Decided: Sep 4, 2009 after 114 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: 4 generations back to K903134 (1991). 6 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014141: Digibio Digtial Blood Pressure Monitor Model D11, Digibio Technology Corp. (2002) Summary page 1.
- K041411: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP, Microlife Corp. (2004) Summary page 1.

## Most influential descendants
- K161846: Automatic Arm Bluetooth Blood Pressure Monitor (2016), 5 descendants of its own
- K192023: Arm Blood Pressure Monitor (2019), 3 descendants of its own
- K220113: Upper Arm Electronic Blood Pressure Monitor (Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) (2022), 2 descendants of its own
- K210671: Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 (2021), 1 descendant of its own
- K181104: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style (2018), 1 descendant of its own

## Indications for use
Truly Automatic Arm Blood Pressure Monitor ,Models DB21, DB22, DB23, DB31, DB32, DB61 M, DB62M, DB63M, DB71M are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K091434
Methodology: https://510kreport.com/methodology