510(k) Report

510(k) · Cleared

Cleared

Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000

K012796510(k) TraditionalCleared Mar 14, 2002205-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

Amluck, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 14, 2002 as substantially equivalent to K001182 (Microlife Corp., 2000) after a 205-day review. Its family tree reaches back 1 generation to 2000. 28 later devices descend from it.

Decided
Mar 14, 2002
Review
205 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001182 (2000). 28 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2011: 3 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2019: 2 descendants cleared2015: 1 descendant cleared2022: 3 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK001182 · Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 · Microlife Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 5 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants8 generations forward: 4 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant K001182 · Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 · Microlife Corp. · 20000+5+10
  1. Root · 1 generation backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
  2. This deviceK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
  3. Descendant · cites it directly · 25 of its ownK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
  4. Descendant · 2 generations on · 24 of its ownK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
  5. Descendant · 3 generations on · 23 of its ownK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
  6. Descendant · 4 generations on · 15 of its ownK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
  7. Descendant · 5 generations on · 8 of its ownK140067 QardioarmQardio, Inc. · 2014

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22008: 12009: 12011: 32012: 22014: 22015: 12016: 12017: 22018: 22019: 22020: 12022: 32023: 12024: 12025: 12026: 1
2004high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 28 · See all
  • K051862PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic…Ya Horng Electronic Co., Ltd. · 2005 · cites it directly25descendants
  • K072860YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood…Ya Horng Electronic Co., Ltd. · 2008 · 2 generations on24descendants
  • K090058YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…Ya Horng Electronic Co., Ltd. · 2009 · 3 generations on23descendants
  • K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionYa Horng Electronic Co., Ltd. · 2012 · 4 generations on15descendants
  • K140067QardioarmQardio, Inc. · 2014 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001182Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp.2000—
0 (this device)K012796Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc.2002—
+1K051862PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R…Ya Horng Electronic Co., Ltd.2005—
+2K072860YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital…Ya Horng Electronic Co., Ltd.2008—
+3K090058YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U…Ya Horng Electronic Co., Ltd.2009—
+4K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth…Ya Horng Electronic Co., Ltd.2012—
+5K140067QardioarmQardio, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200810
200910
201130
201220
201420
201510
201610
201720
201820
201920
202010
202230
202310
202410
202510
202610
FIG. 1 — Lineage of K012796, 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
*K001182Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1
Summary page 1
…NT SYSTEM ( per 21CFR section 870.1130) Class II (performance standards) CARDIOVASCULAR DXN MICROLIFE ~ WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BUI 510(k) No: K001182 AMI.UCK Friterprises Co. Lzrd. No. 41, Ching Hsiang St., Tu-Cheng, Taipei, Taiwan, ROC 236 Telephone: 886-2-22695…
Microlife Corp.2000—

Also cleared against K001182: 1 other device →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K051862PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic…Ya Horng Electronic Co., Ltd.200525
K051863Amluck, YA HorngYa Horng Electronic Co., Ltd.20050
K040528Amluck YA Horng PC Compatible Wrist Blood Pressure Monitor, Model AK-4000TYa Horng Electronic Co., Ltd.20040

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, K051862 (Ya Horng Electronic Co., Ltd., 2005) has gone furthest, with 25 descendants of its own.
  • 1 other device also cites its predicate K001182.

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 Amluck automatic digital wrist blood pressure monitor, Model AK-3000 / AK-4000, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3” — 8.5”.

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

Also cleared against K001182

1 other device cites the same predicate.

  • K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 2007

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/K012796 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012796: Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012796

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026