510(k) · Cleared
ClearedPiesometer, Model MK-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canamet Canadian Natl Medical Technologies, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 24, 2004 as substantially equivalent to K031479 (Datex-Ohmeda, Inc., 2003) and 4 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Aug 24, 2004
- Review
- 112 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K855127 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 1 generation backK031479 Ambulatory Blood Pressure (Abp) 92506 Report Management System…Datex-Ohmeda, Inc. · 2003
- This deviceK041169 Piesometer, Model MK-1Canamet Canadian Natl Medical Technologies, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −1 | K031479 | Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model… | Datex-Ohmeda, Inc. | 2003 | — |
| 0 (this device) | K041169 | Piesometer, Model MK-1 | Canamet Canadian Natl Medical Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 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? (5)
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 |
|---|---|---|---|
| * | K031479 | Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506Summary page 1…sure meter. 2. Equivalent legally marketed devices This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941 167, K904318, K855127 and, SunTech Accutracker DX, K913 844. 3. Indications for Use (intended use) Th… | 2003 |
| * | K941167 | Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)Summary page 1…r. 2. Equivalent legally marketed devices This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941 167, K904318, K855127 and, SunTech Accutracker DX, K913 844. 3. Indications for Use (intended use) The device i… | 1994 |
| * | K904318 | Local Report GeneratorSummary page 1…Equivalent legally marketed devices This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941 167, K904318, K855127 and, SunTech Accutracker DX, K913 844. 3. Indications for Use (intended use) The device is used to… | 1990 |
| * | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202Summary page 1…ent legally marketed devices This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941 167, K904318, K855127 and, SunTech Accutracker DX, K913 844. 3. Indications for Use (intended use) The device is used to provide… | 1986 |
| * | K913844 | Accutracker DXSummary page 1…duct is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941 167, K904318, K855127 and, SunTech Accutracker DX, K913 844. 3. Indications for Use (intended use) The device is used to provide data to qualified medical personnel or trained… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K031479.
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 device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood…
Read the full statement (145 words)
The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician.
Patient diagnosis is not to be performed solely based on the results of this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041169: Piesometer, Model MK-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041169
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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