510(k) Report

FDA applicant

Acueity, Inc.

Palo Alto, CA4 decisions2001–20040 recalls

FDA records 4 decisions for Acueity, Inc. (Palo Alto, CA) from 2001 to 2004: 4 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and GCT (Light Source, Endoscope, Xenon Arc). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Acueity, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Acueity, 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?

  • KNWInstrument, Biopsy1decision
  • GCTLight Source, Endoscope, Xenon Arc1decision
  • FCWLight Source, Fiberoptic, Routine1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K011189Viaduct Microendoscope and AccessoriesAcueity, Inc. · 20016cite it

What has FDA decided for it lately?

  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K032847Excisor Bioptome, Model 01-0004Acueity, Inc. · 2003
  • K032430Acueity Medical Light SourceAcueity, Inc. · 2003
  • K011189Viaduct Microendoscope and AccessoriesAcueity, Inc. · 2001

All 4 as Acueity, Inc. →