510(k) Report

FDA applicant

Iris Medical Ent., Inc.

Washington, DC1 decision1988–19880 recalls

FDA records 1 decision for Iris Medical Ent., Inc. (Washington, DC) in 1988: 1 510(k) clearance. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Iris Medical Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iris Medical Ent., 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?

  • HISCondom1decision

What has FDA decided for it lately?

  • K881735CondomIris Medical Ent., Inc. · 1988

The one decision as Iris Medical Ent., Inc. →

Other applicant names beginning “Iris”

FDA records each applicant name separately; these may or may not be the same firm.

Iris International, Inc. 3Iris Diagnostics 2Iris 1Iris International Inc., A Division of Iris Iris I 1Iris USA 1Iris Optical, Inc. 1Iris Remote Imaging Systems 1Iris Molecular Diagnostics 1Iris Surgical, LLC 1Iris Diagnostics, A Division of Iris International, Inc. 1