510(k) Report

FDA applicant

Advanced Ortho-Technology, Inc.

Tuckahoe, NY3 decisions1985–19860 recalls

FDA records 3 decisions for Advanced Ortho-Technology, Inc. (Tuckahoe, NY) from 1985 to 1986: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and HWN (Instrument, Compression). 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, orthopedic panel, where it files most

How often FDA has decided Advanced Ortho-Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Ortho-Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Ortho-Technology, Inc. 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?

  • FRODressing, Wound, Drug1decision
  • HWNInstrument, Compression1decision

What has FDA decided for it lately?

  • K861937Aquacel Surgical Prep PadsAdvanced Ortho-Technology, Inc. · 1986
  • K854241Aot External Compress DeviceAdvanced Ortho-Technology, Inc. · 1986
  • K854344Aquacel Surgical Prep PadsAdvanced Ortho-Technology, Inc. · 1985

All 3 as Advanced Ortho-Technology, Inc. →