# K100994: Preloaded Tissue Marker Device

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Apr 30, 2010 after 21 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001807 (2001). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042296: Biomarc Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2004) Summary page 1.
- K063193: Modification to Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2006)

## Most influential descendants
- K251989: VizMark Preloaded Tissue Marker Device (VM-0001) (2025), 0 descendants of its own
- K251748: MammoSTAR Biopsy Site Identifier (2025), 0 descendants of its own
- K211590: Fiducial Marker (2021), 0 descendants of its own

## Recalls of this device
- Dec 16, 2022 · Class II · Z-1041-2023: The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded

## Indications for use
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for fiuture surgical procedures.

Source page: https://510kreport.com/device/K100994
Methodology: https://510kreport.com/methodology