# K201921: Spacelabs Lifescreen PRO Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Mar 26, 2021 after 259 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910870 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110001: Spacelabs Pathfinder SL Holter Analyzer, Spacelabs Healthcare, Ltd. (2011) Summary page 4.

## Indications for use
The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

Source page: https://510kreport.com/device/K201921
Methodology: https://510kreport.com/methodology