# K973426: Ans 2000 Ecg Monitor and Respiration Pacer

- Pathway: 510(k) (Traditional)
- Applicant: D. E. Hokanson, Inc.
- Decided: Aug 12, 1998 after 336 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.
31 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991831: BMT Anscore Health Management System, Model 1.1 (1999), 26 descendants of its own
- K993875: BMT Anscore Health Management System (2000), 17 descendants of its own
- K070795: Sphygmocor Cardiovascular Management System (2007), 16 descendants of its own
- K110603: Hypertension Management Software Claient Server (HMS-CS) (2011), 8 descendants of its own
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), 8 descendants of its own

## Indications for use
The ANS2000 is an ECC Monitor and Respiration Pacer that measures heart rate and provides a respiration timer for the purpose of measuring heart rate variations in response to respiration. The instrument was developed for use in studies of patients in which it is important to know the interval between heartbeats and also to synchronize the data analysis with the patient's breathing.

Source page: https://510kreport.com/device/K973426
Methodology: https://510kreport.com/methodology