510(k) Report

FDA applicant

Cit Ortho

Westlake, OH1 decision2021–20212 recalls

FDA records 1 decision for Cit Ortho (Westlake, OH) in 2021: 1 510(k) clearance. All are in product code HRX (Arthroscope). Its devices cite 1 predicate, 0 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, orthopedic panel, where it files most

How often FDA has decided Cit Ortho’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 12025: 1
2021high 1 (2024) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Cit Ortho by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRXArthroscope1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K203526C Scope Visualization SystemCit Ortho · 20212 recalls

The one decision as Cit Ortho →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K203526Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2)…Feb 11, 2025Class II
  • K203526Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2)…Apr 8, 2024Class II