510(k) Report

FDA applicant

Clearcount Medical Solutions, Inc.

Pittsburgh, PA3 decisions2007–20090 recalls

FDA records 3 decisions for Clearcount Medical Solutions, Inc. (Pittsburgh, PA) from 2007 to 2009: 3 510(k) clearances. All are in product code LWH (Counter, Sponge, Surgical). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Clearcount Medical Solutions”.

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 Clearcount Medical Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22009: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • LWHCounter, Sponge, Surgical3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K071355Smartsponge SystemClearcount Medical Solutions, Inc. · 20072cite it
  • K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 20071cites it
  • K093557Smartwand-DTXClearcount Medical Solutions · 20091cites it

What has FDA decided for it lately?

  • K093557Smartwand-DTXClearcount Medical Solutions · 2009
  • K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007
  • K071355Smartsponge SystemClearcount Medical Solutions, Inc. · 2007

All 2 as Clearcount Medical Solutions, Inc. →The one decision as Clearcount Medical Solutions →