510(k) Report

FDA applicant

C.S.O. S.R.L.

Williamsville, NY5 decisions1999–20230 recalls

FDA records 5 decisions for C.S.O. S.R.L. (Williamsville, NY) from 1999 to 2023: 5 510(k) clearances. Most are in product codes HKY (Tonometer, Manual) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cso”.

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 C.S.O. S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12023: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — C.S.O. S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C.S.O. S.R.L.’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?

  • HKYTonometer, Manual2decisions
  • HJOBiomicroscope, Slit-Lamp, Ac-Powered1decision
  • OBOTomography, Optical Coherence1decision
  • HKICamera, Ophthalmic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K992836SL990, SL980, SL950Cso · 19993cite it
  • K022054F 900C.S.O. S.R.L. · 20021cites it

What has FDA decided for it lately?

  • K221601MS-39C.S.O. S.R.L. · 2023
  • K132987Cobra Fundus CameraC.S.O. S.R.L. · 2014
  • K022054F 900C.S.O. S.R.L. · 2002
  • K992835C.S.O. TonometerCso · 2000
  • K992836SL990, SL980, SL950Cso · 1999

All 3 as C.S.O. S.R.L. →All 2 as Cso →