# K180621: EchoMark, EchoMark LP

- Pathway: 510(k) (Traditional)
- Applicant: Sonavex, Inc.
- Decided: Jun 6, 2018 after 89 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: 7 generations back to K001807 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152070: BioZorb LP Marker, Focal Therapeutics (2015) Summary page 4.

## Indications for use
The EchoMark and EchoMark LP are indicated for radiographic marking of sites in soft tissue. In addition, the EchoMark and EchoMark LP are indicated for situations where a soft tissue site needs to be marked for future medical procedures.

Source page: https://510kreport.com/device/K180621
Methodology: https://510kreport.com/methodology