Breast-Med, Inc. · Class II · Cleared Dec 12, 2025
| K-number | K251989 |
| Device name | VizMark Preloaded Tissue Marker Device (VM-0001) |
| Applicant | Breast-Med, Inc. |
| Product code | NEU |
| Device class | Class II |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4300 |
The VizMark Preloaded Tissue Marker Device is a sterile, single-use tissue marker consisting of a gadolinium-filled polymeric tube that is visible on radiographs (x-ray, mammography), ultrasound, and MRI. It is placed into soft tissue during surgical procedures to radiographically mark a surgical location for current or future surgical procedures.
The subject device uses the same tissue marker as the predicate device (identical material composition: PEEK, BaSO4-filled PEEK, and Gd/chelate) and employs the same delivery mechanism as the reference device. Key differences include a new sterile barrier pouch (BOPA/Polyethylene/Foil instead of Tyvek), a detent retention mechanism instead of a nylon sleeve, and extended shelf life of 24 months versus 12 months for the predicate.
Biocompatibility testing was conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (acute systemic toxicity and pyrogenicity). Verification testing included marker delivery, marker integrity, handle pull tests, sterilization, packaging, and shelf life assessments.
View the full FDA submission: accessdata.fda.gov