# K103732: Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) Monitor

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Feb 4, 2011 after 44 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K141113: Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-Invasive (2014), 0 descendants of its own

## Recalls of this device
- Oct 12, 2011 · Not classified · Z-0304-2012: If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code.

## Indications for use
The Spacelabs Model 9021 7A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

Source page: https://510kreport.com/device/K103732
Methodology: https://510kreport.com/methodology