# K060076: Surgicount Safety-Sponge System

- Pathway: 510(k) (Traditional)
- Applicant: Surgicount Medical
- Decided: Mar 14, 2006 after 63 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Tyco/Kendall X-ray detectable surgical sponges: named in the summary without a submission number
- (no number) Tyco BAG-IT Sponge Counting System: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K960036: Firard II/ TDP Lamp, Helio Medical Supplies, Inc. (1996). The summary prints BK960036, a CBER number, which our reading took as K960036, FDA’s number for Firard II/ TDP Lamp (Helio Medical Supplies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SMS Blood Bank Transfusion System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K071355: Smartsponge System (2007), 4 descendants of its own
- K062642: RF Surgical Systems Inc. Detection System, Model 100A (2006), 4 descendants of its own
- 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

## Recalls of this device
- Jun 15, 2022 · Class II · Z-1452-2022: When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update
- Mar 21, 2016 · Class II · Z-1379-2016: The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCount
- Jun 16, 2013 · Class II · Z-0986-2015: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

## Indications for use
The SurgiCount Medical Safety-Sponge SystemTM is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.

Source page: https://510kreport.com/device/K060076
Methodology: https://510kreport.com/methodology