510(k) Report

510(k) · Cleared

Cleared

Pixel App

K120473510(k) TraditionalCleared Apr 9, 201253-day reviewClass I21 CFR 880.2740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gauss Surgical, Inc., · LWH Counter, Sponge, Surgical

Cleared on Apr 9, 2012 as substantially equivalent to K912824 (Devon Industries, Inc., 1991) after a 53-day review. Its family tree reaches back 1 generation to 1991.

Decided
Apr 9, 2012
Review
53 days
Class
Class I
Product code
LWH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K912824 (1991). No later device cites it as a predicate yet.

K912824 · Devon Sponge Counter Bags · Devon Industries, Inc. · 199119901995200020052010
K912824 · Devon Sponge Counter Bags · Devon Industries, Inc. · 19910
  1. Root · 1 generation backK912824 Devon Sponge Counter BagsDevon Industries, Inc. · 1991
  2. This deviceK120473 Pixel AppGauss Surgical, Inc., · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912824Devon Sponge Counter BagsDevon Industries, Inc.1991—
0 (this device)K120473Pixel AppGauss Surgical, Inc.,2012—
FIG. 1 — Lineage of K120473, 1991–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K912824Devon Sponge Counter Bags
Summary page 1
…Device Classification Number: 21 CFR 880.2740 Device Class: Class 1 Proprietary Name: Gauss Pixel App~ Predicate Device Bag-It TM. Sponge Counter Bags (Tyco/Covidien) (K9 12824) Device Description The Gauss Pixel App is a software program used on an iWad tablet to capture images of sponges to assist surg…
Devon Industries, Inc.1991—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All LWH devices

LWH Counter, Sponge, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LWH

2in 2012

2007: 22009: 12010: 12012: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWH

Too few LWH 510(k)s in any year since 2007 to give a median.

Recalls per year · LWH

1in 2013

2013: 12026 (partial year): 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LWH

34in 2025

2007: 12008: 12009: 22010: 32011: 142012: 62013: 52014: 162015: 82016: 402017: 1072018: 642019: 662020: 332021: 352022: 412023: 392024: 372025: 34
2007high 107 (2017) · low 1 (2007)2025

MAUDE reports naming product code LWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20080—01
20091—02
20101—03
20110—014
20122—06
20130—15
20140—016
20150—08
20160—040
20170—0107
20180—064
20190—066
20200—033
20210—035
20220—041
20230—039
20240—037
20250—034
20260—1—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Gauss Surgical, Inc.,

6 FDA decisions under this applicant name. See the company

  • K163507Triton Sponge SystemGauss Surgical, Inc., · 2017
  • K160338Triton SystemGauss Surgical, Inc., · 2016
  • K142801Triton Canister SystemGauss Surgical, Inc., · 20154 recalls
  • DEN130015Pixel 3 SystemGauss Surgical, Inc., · 2014
  • K121274Pixel AppGauss Surgical, Inc., · 2012

Recent decisions in LWH

The LWH category page

  • K121274Pixel AppGauss Surgical, Inc., · 2012
  • K100551Orlocate System Model Orl 100Haldor Advanced Technologies, Ltd. · 2010
  • K093557Smartwand-DTXClearcount Medical Solutions · 2009
  • K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007
  • K071355Smartsponge SystemClearcount Medical Solutions, Inc. · 2007

https://510kreport.com/device/K120473 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120473: Pixel App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120473

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026