# K991831: BMT Anscore Health Management System, Model 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Technologies, Inc.
- Decided: Jun 11, 1999 after 14 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: 2 generations back to K950779 (1995). 3 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972991: Monitor One NDX, Qmed, Inc. (1998) Summary page 1.
- K973426: Ans 2000 Ecg Monitor and Respiration Pacer, D. E. Hokanson, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K071168: The Portable Ansiscope (2007), 7 descendants of its own

## Indications for use
Indications: The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment

Source page: https://510kreport.com/device/K991831
Methodology: https://510kreport.com/methodology