510(k) Report

510(k) · Cleared

Cleared

KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor

K030359510(k) TraditionalCleared Nov 6, 2003276-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 Nov 6, 2003 as substantially equivalent to K001671 (Omron Healthcare, Inc., 2000) after a 276-day review. Its family tree reaches back 1 generation to 2000. 40 later devices descend from it.

Decided
Nov 6, 2003
Review
276 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001671 (2000). 40 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2006: 2 descendants cleared2008: 1 descendant cleared2013: 2 descendants cleared2015: 2 descendants cleared2009: 11 descendants cleared2010: 5 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2018: 3 descendants cleared2017: 2 descendants cleared2011: 2 descendants cleared2020: 1 descendant cleared2023: 3 descendants cleared2016: 1 descendant cleared2026: 1 descendant clearedK001671 · Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 · Omron Healthcare, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants K001671 · Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 · Omron Healthcare, Inc. · 20000+5
  1. Root · 1 generation backK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
  2. This deviceK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
  3. Descendant · cites it directly · 33 of its ownK070826 KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
  4. Descendant · 2 generations on · 8 of its ownK090769 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009
  5. Descendant · 3 generations on · 7 of its ownK091997 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009
  6. Descendant · 2 generations on · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
  7. Descendant · 2 generations on · 6 of its ownK102920 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 12009: 112010: 52011: 22013: 22015: 22016: 12017: 22018: 32020: 12021: 12022: 22023: 32026: 1
2006high 11 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 40 · See all
  • K070826KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007 · cites it directly33descendants
  • K090769Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009 · 2 generations on8descendants
  • K091997Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009 · 3 generations on7descendants
  • K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · 2 generations on6descendants
  • K102920Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001671Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630Omron Healthcare, Inc.2000—
0 (this device)K030359KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co.,2003—
+1K070826KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co.,2007—
+2K090769Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd.2009—
+3K091997Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd.2009—
+2K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd.2015—
+2K102920Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200810
2009110
201050
201120
201320
201520
201610
201720
201830
202010
202110
202220
202330
202610
FIG. 1 — Lineage of K030359, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001671Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630Omron Healthcare, Inc.2000—

Also cleared against K001671: 1 other device →

What descends from it? (40)

See all 40

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

NumberDeviceApplicantDecidedDescendants
K070826KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co.,200733
K052450KD-788 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co.,20063
K080789Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202Sejoy Electronics & Instruments Co., Ltd.20080
K051847KD-768 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co.,20060

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070826 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2007) has gone furthest, with 33 descendants of its own.
  • 1 other device also cites its predicate K001671.

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

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
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

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

What is it indicated for?

The KD-726 Memory Wrist 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.

Also cleared against K001671

1 other device cites the same predicate.

  • K041789Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900TMeditec Co., Ltd. · 2004

More from Kodon (Tianjin)Electronic&Electrical…

9 FDA decisions under this applicant name. See the company

  • K070828KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
  • K070826KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
  • K070395KD-525E Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
  • K052450KD-788 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2006
  • K052676KD-322 Semi Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2006

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K030359 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030359: KD-726 Memory Wrist Automatic Electronic 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/K030359

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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