# K071168: The Portable Ansiscope

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: Aug 31, 2007 after 126 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). 9 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 17 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.
- K991831: BMT Anscore Health Management System, Model 1.1, Boston Medical Technologies, Inc. (1999) Summary page 1.
- K991735: Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K123130: Answatch Wrist Monitor Model TS-0411 (2013), 2 descendants of its own
- K082709: Vicor PD2I Analyzer, Version 2.1 (2008), 1 descendant of its own
- K241217: CloudHRV™ System (100-01-001) (2025), 0 descendants of its own
- K213699: CareTaker Monitor App (2022), 0 descendants of its own
- K201914: HRVWatch-Mini Wrist Monitor (2021), 0 descendants of its own

## Indications for use
The DyAnsys, Inc. ANSiscopeTM ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

Source page: https://510kreport.com/device/K071168
Methodology: https://510kreport.com/methodology