# K061316: Medline Surgical Sponge Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 2, 2006 after 175 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 13, 2008 · Not classified · Z-2321-2008: There is the potential for the RF ID tag to separate from the retaining pouch.

## Indications for use
The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained sponges.

Source page: https://510kreport.com/device/K061316
Methodology: https://510kreport.com/methodology