# K152070: BioZorb LP Marker

- Pathway: 510(k) (Special)
- Applicant: Focal Therapeutics
- Decided: Aug 26, 2015 after 30 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001807 (2001). 13 ancestors in all.
5 later devices descend from it; 4 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143484: BioZorb Marker, Focal Therapeutics (2015) Summary page 4.

## Most influential descendants
- K180640: SmartClip Soft Tissue Marker (2018), 1 descendant of its own
- K233639: SmartClip Secure Soft Tissue Marker (2024), 0 descendants of its own
- K192371: BioZorb SP Marker (2019), 0 descendants of its own
- K180621: EchoMark, EchoMark LP (2018), 0 descendants of its own
- K171467: BioZorb Marker GOLD / LP Marker GOLD (2017), 0 descendants of its own

## Recalls of this device
- Oct 10, 2024 · Class I · Z-0328-2025: Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
- Mar 13, 2024 · Class I · Z-1733-2024: Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the d
- Aug 9, 2022 · Class II · Z-1858-2022: Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the remo

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

Source page: https://510kreport.com/device/K152070
Methodology: https://510kreport.com/methodology