510(k) Report

FDA applicant

Anodyne

O' Fallon, MO2 decisions1990–20160 recalls

FDA records 2 decisions for Anodyne (O' Fallon, MO) from 1990 to 2016: 2 510(k) clearances. Most are in product codes OKS (Lacrimal Stents And Intubation Sets) and FSA (Lift, Patient, Non-Ac-Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Anodyne Corp.”.

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 Anodyne’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Anodyne 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?

  • OKSLacrimal Stents And Intubation Sets1decision
  • FSALift, Patient, Non-Ac-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K160710Oasis Lacrimal Intubation SetAnodyne · 2016
  • K902141Anolift - Portable & Anolift - GantryAnodyne Corp. · 1990

The one decision as Anodyne →The one decision as Anodyne Corp. →