510(k) Report

510(k) · Cleared

Cleared

Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

K012636510(k) TraditionalCleared Oct 26, 200174-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

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

Cleared on Oct 26, 2001 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Oct 26, 2001
Review
74 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK012636 Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Vsm Technology, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK061073 Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement…Taidoc Technology Corporation · 2006
  3. Descendant · 2 generations on · 2 of its ownK062800 Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek…Taidoc Technology Corporation · 2007
  4. Descendant · 3 generations on · 0 of its ownK092875 Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010
  5. Descendant · 3 generations on · 0 of its ownK080014 Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring…Taidoc Technology Corporation · 2008
  6. Descendant · cites it directly · 0 of its ownK023078 Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated…Vsm Medtech, Ltd. · 2003

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12006: 12007: 12008: 12010: 1
2002high 1 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K061073Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250Taidoc Technology Corporation · 2006 · cites it directly3descendants
  • K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever…Taidoc Technology Corporation · 2007 · 2 generations on2descendants
  • K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010 · 3 generations on0descendants
  • K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation · 2008 · 3 generations on0descendants
  • K023078Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood…Vsm Medtech, Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012636Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Vsm Technology, Inc.2001—
+1K061073Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System…Taidoc Technology Corporation2006—
+2K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/…Taidoc Technology Corporation2007—
+3K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation2010—
+3K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation2008—
+1K023078Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated…Vsm Medtech, Ltd.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200610
200710
200810
201010
FIG. 1 — Lineage of K012636, 2001–2010Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K061073Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250Taidoc Technology Corporation20063
K023078Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood…Vsm Medtech, Ltd.20030
K023055Bptru Portable Automated Non-Invasive Blood Pressure Monitor, Model BPM-200Vsm Medtech, Ltd.20020

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?

  • Of its descendants, K061073 (Taidoc Technology Corporation, 2006) has gone furthest, with 3 descendants of its own.

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 BpTRU:

Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older.

Is intended for use in physicians’ offices, nursing units, and patient care areas of hospitals.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Vsm Technology, Inc.

2 FDA decisions under this applicant name. See the company

  • K002046Modification to Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Vsm Technology, Inc. · 2000

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/K012636 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012636: Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012636

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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