De Novo · Granted
GrantedPulsenmore ES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsenmore, Ltd. · SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users
Granted on Oct 31, 2025 as a new device type through De Novo after a 324-day review.
- Decided
- Oct 31, 2025
- Review
- 324 days
- Class
- Class II
- Product code
- SGJ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SGJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SGJ devicesSGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGJ
Too few SGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · SGJ
No recall names SGJ since 2007.
Adverse event reports per year · SGJ
No MAUDE report names SGJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (166 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240074 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240074: Pulsenmore ES.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026