# K120473: Pixel App

- Pathway: 510(k) (Traditional)
- Applicant: Gauss Surgical, Inc.,
- Decided: Apr 9, 2012 after 53 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: 1 generation back to K912824 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912824: Devon Sponge Counter Bags, Devon Industries, Inc. (1991) Summary page 1.

## Indications for use
The Gauss Pixel App is indicated for use to aid current practices in recording the number of surgical sponges and for visibility for assessment of sponge images.

Source page: https://510kreport.com/device/K120473
Methodology: https://510kreport.com/methodology