510(k) · Cleared
ClearedVasocor Vascular Diagnostic Center (Model 300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasocor, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 23, 2002 as substantially equivalent to K961144 (Touritu Engineering Co., Inc., 1997) and 1 other predicate after a 243-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 23, 2002
- Review
- 243 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961144 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961144 MS-2000Touritu Engineering Co., Inc. · 1997
- This deviceK011625 Vasocor Vascular Diagnostic Center (Model 300)Vasocor, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961144 | MS-2000 | Touritu Engineering Co., Inc. | 1997 | — |
| 0 (this device) | K011625 | Vasocor Vascular Diagnostic Center (Model 300) | Vasocor, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K961144 | MS-2000Summary page 1…3. Statement of Equivalence The Vasocor™ Vascular Diagnostic Center (Model 300) is substantially equivalent to two cleared devices: (1) Touritu Engineering’s MS-2000, K961144; and (2) Hypertension Diagnostics, Inc.’s CVProfilor DO-2020 CardioVascular Profiling System, K001948. All three products are non… | 1997 |
| * | K001948 | Cvprofilor D0-2020 Cardiovascular Profiling SystemSummary page 1…uivalent to two cleared devices: (1) Touritu Engineering’s MS-2000, K961144; and (2) Hypertension Diagnostics, Inc.’s CVProfilor DO-2020 CardioVascular Profiling System, K001948. All three products are non-invasive electronic devices that use the oscillometric method of blood pressure measurement to take v… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K961144.
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 Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI)…
Read the full statement (125 words)
The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), ankle/brachial index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have potential underlying vascular disease, including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011625: Vasocor Vascular Diagnostic Center (Model 300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011625
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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