# K031479: Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 6, 2003 after 29 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 K855127 (1986). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202, Spacelabs, Inc. (1986) Summary page 1.

## Most influential descendants
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System (2006), 19 descendants of its own
- K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (2018), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (2007), 4 descendants of its own

## Indications for use
The ABP 92506 RMS is used to provide data to qualified medical personnel for the purpose of assessing the patient’s cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. The data is intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. Patient diagnosis is not to be performed solely based on the results of this device.

Source page: https://510kreport.com/device/K031479
Methodology: https://510kreport.com/methodology