# K031327: Vericor

- Pathway: 510(k) (Traditional)
- Applicant: Cvp Diagnostics, Inc.
- Decided: May 12, 2004 after 383 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900247 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912946: Collins Digital Pulmonary Manometer, Warren E. Collins, Inc. (1992) Summary page 4.
- K900247: CBM-3000/CBM-2000/CBM-7000 Blood Pressure System, Colin Medical Instruments Corp. (1990) Summary page 4.
- (no number) Arrow Balloon Wedge Pressure Catheter: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K031327
Methodology: https://510kreport.com/methodology