# K131064: Biospace

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Corporation Limited
- Decided: Sep 4, 2013 after 141 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 K010828 (2001). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010828: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP, A&D Engineering, Inc. (2001) Summary page 1.

## Most influential descendants
- K200442: InBody (2020), 2 descendants of its own
- K221764: InBody Blood pressure monitor, Model BPBIO480KV (2022), 1 descendant of its own
- K250091: KOROT Blood Pressure Monitor (KOROT P3 Accurate) (2025), 0 descendants of its own
- K231174: BPBIO750 (2023), 0 descendants of its own

## Indications for use
The Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO32On is the same device as the BPB10320 and has same specifications except it has no printer module.)

Source page: https://510kreport.com/device/K131064
Methodology: https://510kreport.com/methodology