# K884152: Century Color Trace

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Systems, Inc.
- Decided: Dec 15, 1988 after 73 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
No predicates in its family tree.
48 later devices descend from it; 3 cite it directly.
0 of 49 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
- K042463: Holter Plus (2004), 35 descendants of its own
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own

Source page: https://510kreport.com/device/K884152
Methodology: https://510kreport.com/methodology