510(k) · Cleared
ClearedVericor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cvp Diagnostics, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 12, 2004 as substantially equivalent to K912946 (Warren E. Collins, Inc., 1992) and 1 other predicate after a 383-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 12, 2004
- Review
- 383 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900247 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900247 CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemColin Medical Instruments Corp. · 1990
- This deviceK031327 VericorCvp Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure System | Colin Medical Instruments Corp. | 1990 | — |
| 0 (this device) | K031327 | Vericor | Cvp Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (3)
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 |
|---|---|---|---|
| * | K912946 | Collins Digital Pulmonary ManometerSummary page 4…ice. The VeriCor device incorporates two independent medical devices that were previously cleared by FDA: The W. E. Collins Airway Pressure Monitor was cleared by FDA as K912946, and the Colin CBM7000 Pulse Tonometer was cleared by FDA as K900247. The VeriCor is substantially equivalent to these two device… | 1992 |
| * | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemSummary page 4…that were previously cleared by FDA: The W. E. Collins Airway Pressure Monitor was cleared by FDA as K912946, and the Colin CBM7000 Pulse Tonometer was cleared by FDA as K900247. The VeriCor is substantially equivalent to these two devices in regard to many of its technological characteristics. B. DEVICE… | 1990 |
| * | — | Arrow Balloon Wedge Pressure Catheter Named without a submission number |
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.
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 VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has…
Read the full statement (189 words)
The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected.
The device has been clinically validated in males only. Use of the device in females has not been investigated. Certain patient conditions should be considered as a basis for excluding individual patients for testing based on a possible risk to them of the Valsalva maneuver, such as the following:
Weight <88 pounds (40 kilograms)*
Atrial flutter or atrial fibrillation with irregular ventricular response
Significant atrial or ventricular ectopy
Hypertrophic obstructive cardiomyopathy
History of paradoxical emboli
Known intracardiac shunt
Significant aortic valvular disease
Unstable angina
History of embolic CVA
Myocardial infarction within one week of intended VeriCor testing
Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP > 100mmHg)
Hypotension (systolic BP<90mmHg)
Symptomatic bradycardia
Known cholesterol emboli
Poor LV function with LV thrombus
*Colin tonometer recommendation
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/K031327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031327: Vericor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031327
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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