510(k) · Cleared

Cleared

KD-795 Wrist Measurement Electronic Blood Pressure Monitor

K070826510(k) TraditionalCleared Aug 15, 2007142-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

Kodon (Tianjin)Electronic&Electrical Apparatus Co., · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Aug 15, 2007 as substantially equivalent to K030359 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2003) after a 142-day review. Its family tree reaches back 2 generations to 2000. 33 later devices descend from it.

Decided: Aug 15, 2007
Review: 142 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K001671 (2000). 33 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 2 generations backK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
1 generation backK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
This deviceK070826 KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
Descendant · cites it directly · 8 of its ownK090769 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009
Descendant · 2 generations on · 7 of its ownK091997 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009
Descendant · cites it directly · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
Descendant · cites it directly · 6 of its ownK102920 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
Descendant · 2 generations on · 5 of its ownK131569 PG-800A SeriesShenzhen Pango Electronic Co., Ltd. · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2009high 11 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 33 · See all

K090769Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009 · cites it directly8descendants
K091997Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009 · 2 generations on7descendants
K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · cites it directly6descendants
K102920Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010 · cites it directly6descendants
K131569PG-800A SeriesShenzhen Pango Electronic Co., Ltd. · 2013 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001671	Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630	Omron Healthcare, Inc.	2000	—
−1	K030359	KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2003	—
0 (this device)	K070826	KD-795 Wrist Measurement Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2007	—
+1	K090769	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961	Andon Health Co, Ltd.	2009	—
+2	K091997	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962	Andon Health Co, Ltd.	2009	—
+1	K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	Fudakang Industrial Co., Ltd.	2015	—
+1	K102920	Electronic Blood Pressure Monitor	Shenzhen Pango Electronic Co., Ltd.	2010	—
+2	K131569	PG-800A Series	Shenzhen Pango Electronic Co., Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	11	0
2010	5	0
2011	2	0
2013	1	0
2015	2	0
2016	1	0
2017	2	0
2018	3	0
2020	1	0
2022	1	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K070826, 2000–2026Source: 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
*	K030359	KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor Summary page 1 …to which equivalence is claimed: Device manufacture 510(k) number KD-726 Kodon (Tianjin) Electronic and K030359 Electrical Co., Ltd. Device description: Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure…	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2003	—

Also cleared against K030359: 3 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K090769	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961	Andon Health Co, Ltd.	2009	8
K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	Fudakang Industrial Co., Ltd.	2015	6
K102920	Electronic Blood Pressure Monitor	Shenzhen Pango Electronic Co., Ltd.	2010	6
K090768	Fully Automatic Electronic Blood Pressure Monitor, Models KD 5901, KD-7909,	Andon Health Co, Ltd.	2009	5
K141683	Electronic Blood Pressure Monitor	Shenzhen Urion Technology Co., Ltd.	2015	0
K092510	Fully Automatic Electronic Blood Pressure Monitor, Models KD-7901, KD-7905, KD-7911	Andon Health Co, Ltd.	2009	0
K083247	Fully Automated Electronic Blood Pressure Monitor, Model KD-7906	Andon Health Co, Ltd.	2009	0
K083248	Fully Automated Electronic Blood Pressure Monitor, Model KD-7902	Andon Health Co, Ltd.	2009	0
K083319	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7941	Andon Health Co, Ltd.	2009	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 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K090769 (Andon Health Co, Ltd., 2009) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K030359.

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. 2007, 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?

Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070826

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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