# K903644: Series 1500 12-Lead Analysis Option

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Dec 27, 1991 after 501 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 2 cite it directly.
4 of 61 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
- K973403: Cardiosmart ST (1998), 34 descendants of its own
- K991014: Case 8000 Exercise Testing System (1999), 33 descendants of its own
- K023380: T-Wave Altermans (Twa) Algorithm Option (2002), 31 descendants of its own
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own
- K973486: Life Pak 12 (1998), 24 descendants of its own

Source page: https://510kreport.com/device/K903644
Methodology: https://510kreport.com/methodology