# K962970: Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Mar 25, 1997 after 237 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933143 (1994). 2 ancestors in all.
150 later devices descend from it; 1 cites it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942058: Spacelabs Medical Ecg Module (Model 90492), Spacelabs Medical, Inc. (1995) Summary page 1.
- K933143: Model Eli 300 Electrocardiograph, Mortara Instrument, Inc. (1994) Summary page 1.

## Most influential descendants
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496 (1998), 149 descendants of its own
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), 75 descendants of its own

## Indications for use
The Spacelabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the Spacelabs Medical Model 90492 ECG module.

Source page: https://510kreport.com/device/K962970
Methodology: https://510kreport.com/methodology