# K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs, Inc.
- Decided: Aug 14, 1986 after 234 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
No predicates in its family tree.
64 later devices descend from it; 6 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983996: Spacelabs Medical Ultraview Digital Telemtry System (1999), 26 descendants of its own
- K031479: Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506 (2003), 21 descendants of its own
- K080192: Hypervisor VI Central Monitoring System (Including TMS) (2008), 20 descendants of its own
- K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System (2006), 19 descendants of its own
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (2014), 17 descendants of its own

Source page: https://510kreport.com/device/K855127
Methodology: https://510kreport.com/methodology