# K014141: Digibio Digtial Blood Pressure Monitor Model D11

- Pathway: 510(k) (Traditional)
- Applicant: Digibio Technology Corp.
- Decided: Sep 13, 2002 after 270 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.
14 later devices descend from it; 2 cite it directly.
0 of 15 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
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M (2009), 11 descendants of its own
- 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
- K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M (2009), 2 descendants of its own

## Indications for use
DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user’s arm.

Source page: https://510kreport.com/device/K014141
Methodology: https://510kreport.com/methodology