# K141113: Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-Invasive

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Sep 26, 2014 after 149 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: 2 generations back to K855127 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103732: Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) Monitor, Spacelabs Healthcare, Ltd. (2011) Summary page 5.

## Indications for use
The Spacelabs Model OnTrak (90227) 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/K141113
Methodology: https://510kreport.com/methodology