510(k) Report

FDA applicant

Cats Tonometer, LLC

Tucson, AZ3 decisions2018–20240 recalls

FDA records 3 decisions for Cats Tonometer, LLC (Tucson, AZ) from 2018 to 2024: 3 510(k) clearances. All are in product code HKY (Tonometer, Manual). Its devices cite 4 predicates, 2 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 Cats Tonometer, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12021: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Cats Tonometer, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HKYTonometer, Manual3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173904CATS Tonometer PrismCats Tonometer, LLC · 20182cite it

What has FDA decided for it lately?

  • K234037CATS-L Tonometer™ PrismCats Tonometer, LLC · 2024
  • K203850CATS®-D Tonometer PrismCats Tonometer, LLC · 2021
  • K173904CATS Tonometer PrismCats Tonometer, LLC · 2018

All 3 as Cats Tonometer, LLC →