510(k) Report

FDA applicant

Blade Works, Inc.

Laguna Niguel, CA3 decisions1999–20020 recalls

FDA records 3 decisions for Blade Works, Inc. (Laguna Niguel, CA) from 1999 to 2002: 3 510(k) clearances. Most are in product codes HNO (Keratome, Ac-Powered) and KYG (Device, Irrigation, Ocular Surgery). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Blade Works, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Blade Works, 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?

  • HNOKeratome, Ac-Powered2decisions
  • KYGDevice, Irrigation, Ocular Surgery1decision

What has FDA decided for it lately?

  • K020079Bladeworks Microkeratome Blade, Model 7061Blade Works, Inc. · 2002
  • K993225Bladeworks Microkeratome BladeBlade Works, Inc. · 2000
  • K993591Bladeworks Disposable Alk TubingBlade Works, Inc. · 1999

All 3 as Blade Works, Inc. →