510(k) · Cleared

Cleared

RA-T59 Wrist blood pressure monitor

K212312510(k) TraditionalCleared Jan 27, 2022188-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

Lotusnine Medical Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jan 27, 2022 as substantially equivalent to K131742 (Omron Healthcare, Inc., 2013) after a 188-day review. Its family tree reaches back 2 generations to 2005.

Decided: Jan 27, 2022
Review: 188 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K042505 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
1 generation backK131742 HEM-6131Omron Healthcare, Inc. · 2013
This deviceK212312 RA-T59 Wrist blood pressure monitorLotusnine Medical Limited · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K042505	Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N	Omron Healthcare, Inc.	2005	—
−1	K131742	HEM-6131	Omron Healthcare, Inc.	2013	—
0 (this device)	K212312	RA-T59 Wrist blood pressure monitor	Lotusnine Medical Limited	2022	—

FIG. 1 — Lineage of K212312, 2005–2022Source: 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

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What was it cleared against? (1)

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
*	K131742	HEM-6131 Summary page 4 …II Panel Cardiovascular 3. Predicate Device Information 510(k) Trade Name Manufacturer Type Number K131742 Model HEM-6131 Omron Healthcare, Inc. Predicate…	Omron Healthcare, Inc.	2013	—

Also cleared against K131742: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K131742.

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. 2022, 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?

The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K212312 · printed Nov 5, 2026

Cite this page

510(k) Report. “K212312: RA-T59 Wrist blood pressure monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212312

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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