# K073180: Smartsponge Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Clearcount Medical Solutions, Inc.
- Decided: Nov 19, 2007 after 6 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060076 (2006). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071355: Smartsponge System, Clearcount Medical Solutions, Inc. (2007) Summary page 1.
- K062642: RF Surgical Systems Inc. Detection System, Model 100A, Rf Surgical Systems, Inc. (2006) Summary page 1.
- (no number) Dukal Corp. X-ray detectable sponges: named in the summary without a submission number

## Most influential descendants
- K093557: Smartwand-DTX (2009), 1 descendant of its own
- K113021: Trufreeze System, Trufreeze Spray Kit (2012), 0 descendants of its own

## Indications for use
The ClearCount Medical Solutions SmartSponge™ PLUS System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures, as well as for providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.

Source page: https://510kreport.com/device/K073180
Methodology: https://510kreport.com/methodology