Pulsenmore, Ltd.: FDA clearances and approvals
Pulsenmore, Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov. It files with the SEC as Pulsenmore Ltd. (PLSM).
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SGJ | Ultrasound Imaging System For Acquiring Images At Home By Lay Users | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240074 | De Novo | Ultrasound Imaging System For Acquiring Images At Home By Lay Users | 2025-10-31 |
Recalls
openFDA lists no recalls under a recalling firm named Pulsenmore, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Pulsenmore, Ltd. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06442358: Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept (Completed, started 2024-04-10)
- NCT06567067: Human Factoring Validation of Pulsenmore ES Device (Completed, started 2023-02-09)
- NCT07028060: Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC™ Device - Feasibility Study (Completed, started 2022-12-15)
- NCT05329077: Pulsenmore ES Device, Efficacy and Safety Assessment (Completed, started 2022-04-14)
- NCT04399408: Instinct™ Ultrasound Device Safety, Efficacy and Usability (Completed, started 2019-05-06)
SEC filings
Pulsenmore Ltd. (PLSM): EDGAR filings, CIK 2064764. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Pulsenmore, Ltd. have?
Pulsenmore, Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Pulsenmore, Ltd. make?
Its most frequent FDA product codes are SGJ (Ultrasound Imaging System For Acquiring Images At Home By Lay Users, 1).
Has Pulsenmore, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pulsenmore, Ltd. Related entities may recall under other names.
Next steps
- See all 0 Pulsenmore, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code SGJ, Pulsenmore, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.