# K895208: Zymed Model 1610

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies
- Decided: Dec 12, 1989 after 117 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K962930: Spacelabs Medical Ecg Analysis System (1997), 2 descendants of its own
- K063490: Spacelabs Medical Full Disclosure System, Model 91810 (2007), 1 descendant of its own
- K003940: 2010 Plus Holter for Windows (2001), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own
- K110779: Spacelabs Smart Disclosure System (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K895208
Methodology: https://510kreport.com/methodology