# K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Oct 27, 1994 after 727 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.
155 later devices descend from it; 5 cite it directly.
0 of 156 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
- K952912: Spacelabs Medical Integrated Multi-Parameter Module (1997), 150 descendants of its own
- 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

## Recalls of this device
- Jul 18, 2008 · Not classified · Z-1652-2008: Telemetry Modules are failing to alarm for low heart rate and asystole.
- May 5, 2006 · Not classified · Z-1202-06: Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

Source page: https://510kreport.com/device/K925510
Methodology: https://510kreport.com/methodology