Endomagnetics Ltd.,: FDA clearances and approvals
Endomagnetics Ltd., has 5 FDA 510(k) clearances (first 2016, latest 2024), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 123 days. Since 2017 its median was 106 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Endomagnetics Ltd.,. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 135 |
| 2017 | 1 | 28 |
| 2018 | 1 | 88 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 123 |
| 2024 | 1 | 287 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Endomagnetics Ltd.,'s cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 3 | 3 |
| PBY | Temporary Tissue Marker | 2 | 2 |
| PUV | Lymph Node Location System During Sentinel Biopsy Procedure | 1 | 0 |
Review panels
Most recent Endomagnetics Ltd., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232865 | Magseed Pro Magnetic Marker System | NEU | 2024-06-28 | 287 |
| K222832 | Sentimag System | NEU | 2023-01-21 | 123 |
| K173587 | Magseed Magnetic Marker Systtem | NEU | 2018-02-16 | 88 |
| K163541 | Magseed Magnetic Marker System | PBY | 2017-01-13 | 28 |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | PBY | 2016-03-02 | 135 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160053 | PMA | MagtraceTM and Sentimag(R) Magnetic Locatization System | 2018-07-24 |
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2025-10-01.
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
Endomagnetics Ltd., is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05142787: Magseed Pro(R)/ Sentimag(R) Gen3 (Recruiting, started 2023-03-02)
- NCT03796559: Magseed Enabled Long-Term Localization of Axillary Lymph Nodes (Recruiting, started 2019-06-13)
- NCT03020888: Magseed Magnetic Marker Localization (Completed, started 2017-01)
- NCT02336737: SentiMag® Intraoperative Comparison in Breast Cancer (Completed, started 2015-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Endomagnetics Ltd.,'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Endomagnetics Ltd., have?
Endomagnetics Ltd., has 5 FDA 510(k) clearances (first 2016, latest 2024), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Endomagnetics Ltd.,'s 510(k)s?
The median time from FDA receipt to decision across Endomagnetics Ltd.,'s cleared 510(k)s is 123 days. Since 2017: 106 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Endomagnetics Ltd., make?
Its most frequent FDA product codes are NEU (Marker, Radiographic, Implantable, 3); PBY (Temporary Tissue Marker, 2); PUV (Lymph Node Location System During Sentinel Biopsy Procedure, 1).
Has Endomagnetics Ltd., had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Endomagnetics Ltd.,; the most recent began 2025-10-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Endomagnetics Ltd., clearances with predicates and recalls
- Run predicate analysis for product code NEU, Endomagnetics 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.