# K161846: Automatic Arm Bluetooth Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Limited
- Decided: Oct 24, 2016 after 111 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: 6 generations back to K001182 (2000). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121025: YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission, Ya Horng Electronic Co., Ltd. (2012) Summary page 4.
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M, Truly Instrument Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- 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
- K252769: Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (2025), 0 descendants of its own
- K242721: Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (2024), 0 descendants of its own
- K170545: Automatic Wrist Bluetooth Blood Pressure Monitor (2017), 0 descendants of its own

## Indications for use
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 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 will display a alert signal with the reading when irregular heartbeat is detected. The devices’ feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Source page: https://510kreport.com/device/K161846
Methodology: https://510kreport.com/methodology