# K093473: KMD-MARK1 Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Kent Medical Devices, Inc.
- Decided: Jul 2, 2010 after 238 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001807 (2001). 11 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072219: Cytophil Tissue Marker, Cytophil, Inc. (2008) Summary page 1.
- K070436: Biomarc Gold Tissue Marker, Carbon Medical Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K130763: Beacon Tissue Marker (2013), 5 descendants of its own
- K140835: General and Plastic Surgery (2014), 3 descendants of its own
- K133697: Breast-Med Tissue Marker (2015), 1 descendant of its own
- K251989: VizMark Preloaded Tissue Marker Device (VM-0001) (2025), 0 descendants of its own
- K230836: SchurSign Tissue Marker (2024), 0 descendants of its own

## Indications for use
The KMD-Markl Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K093473
Methodology: https://510kreport.com/methodology