# K010758: Heartwave Alternans Processing System, Aps

- Pathway: 510(k) (Special)
- Applicant: Cambridge Heart, Inc.
- Decided: Apr 12, 2001 after 30 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K013565: Cardiac Diagnostic System, Model CH2000 (2001), 3 descendants of its own
- K022149: Cardiac Diagnostic System, Model CH2000 (2002), 2 descendants of its own
- K050225: Heartwave II Cardiac Diagnostic System (2005), 1 descendant of its own
- K013564: Modification to Heartwave Alternans Processing System, Model Aps (2001), 1 descendant of its own
- K100362: Cambridge Heart Oem (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K010758
Methodology: https://510kreport.com/methodology