510(k) Report

FDA applicant

Haag-Streit USA, Inc.

Rockville, MD1 decision2005–20050 recalls

FDA records 1 decision for Haag-Streit USA, Inc. (Rockville, MD) in 2005: 1 510(k) clearance. All are in product code HJK (Lens, Contact, Polymethylmethacrylate…). Its devices cite 3 predicates, 0 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, ophthalmic panel, where it files most

How often FDA has decided Haag-Streit USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Haag-Streit USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Haag-Streit USA, 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?

  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005

The one decision as Haag-Streit USA, Inc. →

Other applicant names beginning “Haag-Streit”

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

Haag-Streit AG 4Haag-Streit Holding AG 1