510(k) · Cleared

Cleared

Answatch Wrist Monitor Model TS-0411

K123130510(k) TraditionalCleared Sep 17, 2013348-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Taiwan Scientific Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Sep 17, 2013 as substantially equivalent to K990638 (Genmed, Inc., 1999) and 4 other predicates after a 348-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.

Decided: Sep 17, 2013
Review: 348 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K963725 (1997). 20 ancestors in all, the oldest K820885 (1982). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
3 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
2 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
1 generation backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
This deviceK123130 Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013
Descendant · cites it directly · 0 of its ownK213699 CareTaker Monitor AppCaretaker Medical, LLC · 2022
Descendant · cites it directly · 0 of its ownK201914 HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021

Most influential descendants

Showing 2 of 2 · See all

K213699CareTaker Monitor AppCaretaker Medical, LLC · 2022 · cites it directly0descendants
K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K963725	Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)	Card Guard, Ltd.	1997	—
−3	K012012	Ecg Home	H&C Medical Devices Spa	2002	—
−2	K042814	Readmyheart	Dailycare Biomedical, Inc.	2005	—
−1	K050620	Readmyheart, Model RMH3.0	Dailycare Biomedical, Inc.	2005	—
0 (this device)	K123130	Answatch Wrist Monitor Model TS-0411	Taiwan Scientific Corporation	2013	—
+1	K213699	CareTaker Monitor App	Caretaker Medical, LLC	2022	—
+1	K201914	HRVWatch-Mini Wrist Monitor	Taiwan Scientific Corporation	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1990	1	0
1993	1	0
1994	1	0
1995	1	0
1997	1	0
1998	2	0
1999	3	0
2000	1	0
2002	1	0
2003	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2022	1	0

FIG. 1 — Lineage of K123130, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K990638	Aneroid Sphygmomanometer Summary page 1 …asive blood pressure meter system Classification Name: Noninvasive blood pressure measurement system 5.4 Predicate Devices: The Aneroid Mercury Sphygmomanometer K990638 The KD-788 Wrist Measurement Electronic Blood Pressure Monitor K052450 The Philips Pagewriter Touch Cardiograph K020708 The Po…	Genmed, Inc.	1999	—
*	K052450	KD-788 Wrist Measurement Electronic Blood Pressure Monitor Summary page 1 …d pressure measurement system 5.4 Predicate Devices: The Aneroid Mercury Sphygmomanometer K990638 The KD-788 Wrist Measurement Electronic Blood Pressure Monitor K052450 The Philips Pagewriter Touch Cardiograph K020708 The Portable ANSiscope K071 188 The ReadMyHeart - Model RMHI13 K0…	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2006	—
*	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series Summary page 1 …s: The Aneroid Mercury Sphygmomanometer K990638 The KD-788 Wrist Measurement Electronic Blood Pressure Monitor K052450 The Philips Pagewriter Touch Cardiograph K020708 The Portable ANSiscope K071 188 The ReadMyHeart - Model RMHI13 K050620 5.5 Device Description: The non-invasive bloo…	Philips Medical Systems, Inc.	2002	2
*	K071168	The Portable Ansiscope 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”.	Dyansys, Inc.	2007	—
*	K050620	Readmyheart, Model RMH3.0 Summary page 1 …Electronic Blood Pressure Monitor K052450 The Philips Pagewriter Touch Cardiograph K020708 The Portable ANSiscope K071 188 The ReadMyHeart - Model RMHI13 K050620 5.5 Device Description: The non-invasive blood pressure measuring system HRV Watch Wrist Monitor measures blood pressures (BP) (…	Dailycare Biomedical, Inc.	2005	—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K213699	CareTaker Monitor App	Caretaker Medical, LLC	2022	0
K201914	HRVWatch-Mini Wrist Monitor	Taiwan Scientific Corporation	2021	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
1 of the 20 ancestors has a recall of any class.
Of its descendants, K213699 (Caretaker Medical, LLC, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123130: Answatch Wrist Monitor Model TS-0411.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123130

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026