510(k) Report

FDA applicant

Benz Research and Development Corp.

Sarasota, FL12 decisions1995–20100 recalls

FDA records 12 decisions for Benz Research and Development Corp. (Sarasota, FL) from 1995 to 2010: 12 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HQD (Lens, Contact (Other Material) - Daily). Its devices cite 2 predicates, 1 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 Benz Research and Development Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Benz Research and Development Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Benz Research and Development Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear10decisions
  • HQDLens, Contact (Other Material) - Daily2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 1 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.

  • K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a…Benz Research and Development Corp. · 199711cite it
  • K992692Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 19996cite it
  • K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 20073cite it
  • K952620Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp. · 19953cite it
  • K961103Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 19963cite it
  • K980418Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses…Benz Research and Development Corp. · 19982cite it

What has FDA decided for it lately?

  • K101122Benz-G 4X (Hioxifilcon D) Multifocal Lathed LensBenz Research and Development Corp. · 2010
  • K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
  • K003861Benz-MF (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens (Lathe-Cut)Benz Research and Development Corp. · 2001
  • K992692Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
  • K983773Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact LensBenz Research and Development Corp. · 1998
  • K980418Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses…Benz Research and Development Corp. · 1998
  • K972807(Lenses)Benz Hefilcon a Spherical/Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue or Light…Benz Research and Development Corp. · 1997
  • K963744Benz B36 (Kolfocon B) Rigid Gas Permeable (Hydrophobic) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens…Benz Research and Development Corp. · 1997

All 12 as Benz Research and Development Corp. →