510(k) Report

FDA applicant

Volk Optical, Inc.

Rockville, MD4 decisions1994–20152 recalls

FDA records 4 decisions for Volk Optical, Inc. (Rockville, MD) from 1994 to 2015: 4 510(k) clearances. All are in product code HJK (Lens, Contact, Polymethylmethacrylate…). Its devices cite 5 predicates, 4 of them its own earlier devices. 2 recalls are 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 Volk Optical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2015: 12025: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Volk Optical, 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, Diagnostic4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K943125Quadraspheric Fundus LensVolk Optical, Inc. · 19943cite it
  • K023221Contact Laser & Diagnostic LensesVolk Optical, Inc. · 20022cite it
  • K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV DVolk Optical, Inc. · 20052cite it
  • K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 20151cites it

What has FDA decided for it lately?

  • K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
  • K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV DVolk Optical, Inc. · 20051 recall
  • K023221Contact Laser & Diagnostic LensesVolk Optical, Inc. · 20021 recall
  • K943125Quadraspheric Fundus LensVolk Optical, Inc. · 1994

All 4 as Volk Optical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K050623Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk…Dec 16, 2025Class II
  • K023221Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk…Feb 27, 2015Class III