K251989 is an FDA 510(k) clearance for the VizMark Preloaded Tissue Marker Device (VM-0001). This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Breast-Med, Inc. (Hopkins, US). The FDA issued a Cleared decision on December 12, 2025, 168 days after receiving the submission on June 27, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K251989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU - Marker, Radiographic, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |