# K071355: Smartsponge System

- Pathway: 510(k) (Traditional)
- Applicant: Clearcount Medical Solutions, Inc.
- Decided: May 24, 2007 after 9 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- K060076: Surgicount Safety-Sponge System, Surgicount Medical (2006) Summary page 1.
- DEN040007: Implantable Radio Frequency Transponder System. Our reading of the summary gave K033440, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040007, Implantable Radio Frequency Transponder System (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- (no number) Dukal Corporation X-ray detectable surgical sponges: named in the summary without a submission number

## Most influential descendants
- K073180: Smartsponge Plus System (2007), 2 descendants of its own
- K093557: Smartwand-DTX (2009), 1 descendant of its own
- K113021: Trufreeze System, Trufreeze Spray Kit (2012), 0 descendants of its own
- K100551: Orlocate System Model Orl 100 (2010), 0 descendants of its own

## Indications for use
The ClearCount Medical Solutions SmartSponge TM System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparotomy sponges, and surgical towels used during surgical procedures.

Source page: https://510kreport.com/device/K071355
Methodology: https://510kreport.com/methodology