510(k) · Cleared
ClearedBpcalibrator MC3000/MC3100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthstats International Pte., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 24, 2005 as substantially equivalent to K982481 (A&D Engineering, Inc., 1998) after an 11-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Jun 24, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982481 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- This deviceK051546 Bpcalibrator MC3000/MC3100Healthstats International Pte., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK131788 Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP…Healthstats International Pte., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK121266 CardioscopePulsecor Limited · 2012
Most influential descendants
Showing 3 of 3 · See all- K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010 · cites it directly2descendants
- K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd. · 2014 · 2 generations on0descendants
- K121266CardioscopePulsecor Limited · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| 0 (this device) | K051546 | Bpcalibrator MC3000/MC3100 | Healthstats International Pte., Ltd. | 2005 | — |
| +1 | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | Healthstats International Pte., Ltd. | 2010 | — |
| +2 | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management… | Healthstats International Pte., Ltd. | 2014 | — |
| +2 | K121266 | Cardioscope | Pulsecor Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K982481 | A&D Medical UA-767PC Digital Blood Pressure MonitorSummary page 1…Product Code: 74 DXN, 21 CFR § 870.1130 Class: Class 1I (3) Predicate Device(s): K982481 UA-767PC Digital Blood Pressure Monitor, A & 0 Medical Reason for Submission: New Device… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | 2010 | 2 |
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?
How does its category compare?
All DXN devicesDXN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 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 BPCalibrator TM MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and-pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42…
Read the full statement (126 words)
The BPCalibrator TM MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and-pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm).
The BPCalibrator TM MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.
Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051546: Bpcalibrator MC3000/MC3100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051546
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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