# K252892: SCOUT MD Surgical Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 19, 2025 after 99 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: 2 generations back to K181007 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231468: SCOUT MD Surgical Guidance System, Merit Medical System, Inc. (2024) Summary page 5.

## Recalls of this device
- Aug 27, 2026 · Class II · Z-0187-2027: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

## Indications for use
The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Source page: https://510kreport.com/device/K252892
Methodology: https://510kreport.com/methodology