# K842616: Spacelabs Alpha PC Patient Computer

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs, Inc.
- Decided: Oct 18, 1984 after 105 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
165 later devices descend from it; 2 cite it directly.
0 of 166 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
- K972282: Spacelabs Medical Pcis Patient Monitors (1997), 124 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

## Recalls of this device
- Aug 27, 2012 · Class II · Z-2382-2012: There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the ho
- Sep 16, 2005 · Not classified · Z-0063-06: ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.

Source page: https://510kreport.com/device/K842616
Methodology: https://510kreport.com/methodology