# K121964: Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10ML

- Pathway: 510(k) (Traditional)
- Applicant: Augmenix, Inc.
- Decided: Jan 23, 2013 after 202 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: 3 generations back to K970817 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001807: Tissue Marker, Advanced Uroscience, Inc. (2001) Summary page 1.
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker, Bioform, Inc. (2001) Summary page 1.

## Indications for use
TracelT Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.

Source page: https://510kreport.com/device/K121964
Methodology: https://510kreport.com/methodology