# K123130: Answatch Wrist Monitor Model TS-0411

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Scientific Corporation
- Decided: Sep 17, 2013 after 348 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990638: Aneroid Sphygmomanometer, Genmed, Inc. (1999) Summary page 1.
- K052450: KD-788 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2006) Summary page 1.
- K020708: Philips Pagewriter Touch Cardiograph, Model M5000A Series, Philips Medical Systems, Inc. (2002) Summary page 1.
- K071168: The Portable Ansiscope, Dyansys, Inc. (2007). Our reading of the summary gave K071188, FDA’s number for Modification to Jbaids Anthrax Detection System (Idaho Technology, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Portable ANSiscope”.
- K050620: Readmyheart, Model RMH3.0, Dailycare Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K213699: CareTaker Monitor App (2022), 0 descendants of its own
- K201914: HRVWatch-Mini Wrist Monitor (2021), 0 descendants of its own

## Indications for use
Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HIR), heart rate variability (HRV), and irregular heartbeats (Ir-rHB) for professionals at office or patients at home under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. The device provides a I-WV parameter which is only mathematical, analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

Source page: https://510kreport.com/device/K123130
Methodology: https://510kreport.com/methodology