# K993875: BMT Anscore Health Management System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Technologies, Inc.
- Decided: Aug 11, 2000 after 270 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
Longest line of descent: 3 generations back to K950779 (1995). 4 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991831: BMT Anscore Health Management System, Model 1.1, Boston Medical Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K122129: Sphygmocor Xcel (2012), 6 descendants of its own
- K140928: ABPM7100 (2014), 5 descendants of its own

## Indications for use
The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.

Source page: https://510kreport.com/device/K993875
Methodology: https://510kreport.com/methodology