# Healthstats International Pte., Ltd.

- Location (FDA's records): Egale, WI
- FDA decisions: 7 (2005–2018): 7 510(k) clearances
- Product codes: DXN (7)
- Predicates its devices cite: 18 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- A&D Engineering, Inc.: 2 (https://510kreport.com/company/a-d-engineering)
- Omron Healthcare, Inc.: 2 (https://510kreport.com/company/omron-healthcare)
- Atcor Medical: 2 (https://510kreport.com/company/atcor-medical)
- Colin Medical Instruments Corp.: 1 (https://510kreport.com/company/colin-medical-instruments)
- Spacelabs, Inc.: 1 (https://510kreport.com/company/spacelabs)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- I.E.M. GmbH: 1 (https://510kreport.com/company/iem)

## Firms that cite its devices most
- Pulsecor Limited: 1 (https://510kreport.com/company/pulsecor)
- Biobeat Technologies, Ltd.: 1 (https://510kreport.com/company/biobeat-technologies)

## Its most-cited devices
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System (2006), cited by 4
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (2007), cited by 2
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (2010), cited by 2
- K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (2018), cited by 1
- K051546: Bpcalibrator MC3000/MC3100 (2005), cited by 1

## Recent decisions
- K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (Jun 21, 2018)
- K131916: Bprosoft Casp PC Software (Mar 11, 2014)
- K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software (Mar 4, 2014)
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (Jun 8, 2010)
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (Nov 15, 2007)
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System (Apr 7, 2006)
- K051546: Bpcalibrator MC3000/MC3100 (Jun 24, 2005)

Source page: https://510kreport.com/company/healthstats-international