510(k) Report

FDA applicant

Gauss Surgical, Inc.,

Los Altos, CA6 decisions2012–20174 recalls

FDA records 6 decisions for Gauss Surgical, Inc., (Los Altos, CA) from 2012 to 2017: 5 510(k) clearances and 1 De Novo grant. Most are in product codes PBZ (Image Processing Device For Estimation Of…) and LWH (Counter, Sponge, Surgical). Its devices cite 4 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Gauss Surgical, Inc.,’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 22014: 12015: 12016: 12017: 1
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2023

2020: 12023: 3
2012high 3 (2023) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Gauss Surgical, Inc., by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gauss Surgical, Inc.,’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PBZImage Processing Device For Estimation Of External Blood Loss4decisions
  • LWHCounter, Sponge, Surgical2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN130015Pixel 3 SystemGauss Surgical, Inc., · 20142cite it
  • K160338Triton SystemGauss Surgical, Inc., · 20161cites it
  • K163507Triton Sponge SystemGauss Surgical, Inc., · 20171cites it

What has FDA decided for it lately?

  • 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
  • K120473Pixel AppGauss Surgical, Inc., · 2012

All 6 as Gauss Surgical, Inc., →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K142801Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of…Jan 25, 2023Class II
  • K142801Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog…Jan 25, 2023Class II
  • K142801Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog…Jan 25, 2023Class II
  • K142801Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019…Jan 22, 2020Class II