510(k) · Cleared

Cleared

Model DS-1901 Digital Blood Pressure Monitor

K050697510(k) TraditionalCleared Mar 25, 20057-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

Nihon Seimitsu Sokki Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 25, 2005 as substantially equivalent to K993890 (Nihon Seimitsu Sokki Co., Ltd., 1999) after a 7-day review. Its family tree reaches back 2 generations to 1985. 77 later devices descend from it.

Decided: Mar 25, 2005
Review: 7 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K850316 (1985). 77 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
1 generation backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
This deviceK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
Descendant · cites it directly · 55 of its ownK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
Descendant · 2 generations on · 54 of its ownK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
Descendant · 2 generations on · 53 of its ownK122154 Powerplay Muscle MassagerFig, LLC · 2012
Descendant · 3 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
Descendant · 4 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2007high 13 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 77 · See all

K071596Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008 · cites it directly55descendants
K092435Verseo Air Pressure MassagerThe American Export Group & International Services · 2010 · 2 generations on54descendants
K122154Powerplay Muscle MassagerFig, LLC · 2012 · 2 generations on53descendants
K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 3 generations on51descendants
K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 4 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K850316	Unisonic Electronic Digital BP Monitor Ebm-2050	Nihon Seimitsu Sokki Co., Ltd.	1985	—
−1	K993890	Digital Blood Pressure Monitor, Model DS-181	Nihon Seimitsu Sokki Co., Ltd.	1999	—
0 (this device)	K050697	Model DS-1901 Digital Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	2005	—
+1	K071596	Potable Air Massager Putifino, Model AM-7	Nihon Seimitsu Sokki Co., Ltd.	2008	—
+2	K092435	Verseo Air Pressure Massager	The American Export Group & International Services	2010	—
+2	K122154	Powerplay Muscle Massager	Fig, LLC	2012	—
+3	K160608	NormaTec Pulse and NormaTec Pulse Pro	NormaTec Industries, LP	2016	—
+4	K182668	Rapid Reboot Compression Therapy System	Rapid Reboot Recovery Products, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	2	0
2010	2	0
2012	5	0
2013	2	0
2014	1	0
2015	1	0
2016	4	0
2018	3	0
2019	3	0
2020	7	0
2021	13	0
2022	11	0
2023	3	0
2024	6	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K050697, 1985–2026Source: 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
*	K993890	Digital Blood Pressure Monitor, Model DS-181 Summary page 1 …to which substantial equivalence will be demonstrated is the Nissei Model DS-181 Digital Blood Pressure Monitor. This device was cleared for marketing under 510(k) No. K993890, SE decision December 3, 1999. The subject device is essentially an updating of the predicate device. As can be seen in Appen…	Nihon Seimitsu Sokki Co., Ltd.	1999	—

Also cleared against K993890: 3 other devices →

What descends from it? (77)

See all 77

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

Number	Device	Applicant	Decided	Descendants
K071596	Potable Air Massager Putifino, Model AM-7	Nihon Seimitsu Sokki Co., Ltd.	2008	55
K071384	Modification to: Digital Blood Pressure Monitor, Model 1901	Nihon Seimitsu Sokki Co., Ltd.	2007	20

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 20 years and passes through 1 company; a new generation was cleared every 14.6 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K071596 (Nihon Seimitsu Sokki Co., Ltd., 2008) has gone furthest, with 55 descendants of its own.
3 other devices also cite its predicate K993890.

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.

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 DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050697 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050697: Model DS-1901 Digital Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050697

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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