# K110001: Spacelabs Pathfinder SL Holter Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Jun 14, 2011 after 162 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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: 5 generations back to K910870 (1991). 12 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993620: Impresario, Del Mar Medical Systems, LLC (1999) Summary page 2.
- K951902: Pathfinder 700 Holter Analyzer, Reynolds Medical, Ltd. (1996) Summary page 2.
- K042745: Lifescreen Apnea, Del Mar Reynolds Medical, Inc. (2005) Summary page 2.

## Most influential descendants
- K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor) (2011), 4 descendants of its own
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), 3 descendants of its own
- K131883: Audicor Cpam with SDB (Accelerometer Based) (2014), 1 descendant of its own
- K201921: Spacelabs Lifescreen PRO Analyzer (2021), 0 descendants of its own
- K151433: AUDICOR CA300/CC100 Analyzer with SDB (2016), 0 descendants of its own

## Recalls of this device
- May 11, 2012 · Class II · Z-1831-2012: The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc va

## Indications for use
The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use. The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Source page: https://510kreport.com/device/K110001
Methodology: https://510kreport.com/methodology