# K946281: Eclipse 4 Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Burdick, Inc.
- Decided: Apr 23, 1996 after 483 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.
19 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Marquette MAC PC: named in the summary without a submission number

## Most influential descendants
- K031970: Infinity Megacare (2003), 14 descendants of its own
- K050858: Ascentia Heartstation Ecg Management System (2005), 13 descendants of its own
- K061905: Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 (2006), 8 descendants of its own
- K113515: Horizon Cardiology Ecg Management (2012), 7 descendants of its own
- K133534: Mckesson Cardiology Ecg Mobile (2014), 6 descendants of its own

Source page: https://510kreport.com/device/K946281
Methodology: https://510kreport.com/methodology