# K211557: EndoPATx

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical, Ltd.
- Decided: Dec 29, 2022 after 589 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: 2 generations back to K001852 (2001). 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)
- K032519: Endo Pat 2000, Itamar Medical (2003) Summary page 4.

## Indications for use
The EndoPATx 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 EndoPATx 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 EndoPATx 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 conjunction with knowledge of the patient’s history and other clinical findings.

Source page: https://510kreport.com/device/K211557
Methodology: https://510kreport.com/methodology