510(k) Report

FDA applicant

Surgicount Medical

Yorba Linda, CA1 decision2006–20063 recalls

FDA records 1 decision for Surgicount Medical (Yorba Linda, CA) in 2006: 1 510(k) clearance. All are in product code LWH (Counter, Sponge, Surgical). 3 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 Surgicount Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgicount Medical since 2007.

Recalls per year

1in 2022

2013: 12016: 12022: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgicount Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LWHCounter, Sponge, Surgical1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K060076Surgicount Safety-Sponge SystemSurgicount Medical · 20063cite it

What has FDA decided for it lately?

  • K060076Surgicount Safety-Sponge SystemSurgicount Medical · 20063 recalls

The one decision as Surgicount Medical →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K060076SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090.…Jun 15, 2022Class II
  • K060076SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers…Mar 21, 2016Class II
  • K060076The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are…Jun 16, 2013Class II