# DEN240074: Pulsenmore ES

- Pathway: De Novo (Direct)
- Applicant: Pulsenmore, Ltd.
- Decided: Oct 31, 2025 after 324 days
- Product code: SGJ (Ultrasound Imaging System For Acquiring Images At Home By Lay Users)
- Device class: 2
- Regulation: 21 CFR 892.1590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Pulsenmore ES ultrasound system is intended to enable the acquisition of ultrasound images that allow interpreting healthcare providers to determine fetal heart rate. The Pulsenmore ES Ultrasound System is intended for limited diagnostic ultrasound imaging in B-Mode and M-Mode in Fetal/Obstetric applications, when traditional scanning at a health clinic is impractical or when the use of telehealth (clinician-guided mode) or software-guided self-scanning (App-guided mode) is in the best interests of the patient. The device is intended to be used by pregnant women with a singleton pregnancy at the gestational age of 14-38 weeks, when clinically indicated to determine the heart rate on the order of a physician in non-clinical environments. When directed by their physician, the patient can either follow the steps specified by the ES software application (app-guided mode) or under the direction of a healthcare professional (clinician-guided mode). A physician interprets the images acquired with the device in a remote access setup. Access to the device operation must be granted by healthcare professionals.

Source page: https://510kreport.com/device/DEN240074
Methodology: https://510kreport.com/methodology