# K032519: Endo Pat 2000

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical
- Decided: Nov 12, 2003 after 89 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K001852 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001852: Peripheral Arterial Tonometer-Pat 1000RD Device, Itamar Medical (C.M.) 1997, Ltd. (2001)

## Most influential descendants
- K211557: EndoPATx (2022), 0 descendants of its own
- K060980: Vendys Model 5000 B/BC (2007), 0 descendants of its own

## Indications for use
The Endo-PAT2000 device is a non-invasive device, intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive hyperemia procedure. The Endo-PAT2000 has been shown to be predictive of coronary artery Endothelial Dysfunction in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals The Endo-PAT2000 device is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician’s decision-making process. It should be used in conjvnction with knowledge of the patient’s history and other clinical findings.

Source page: https://510kreport.com/device/K032519
Methodology: https://510kreport.com/methodology