510(k) Report

FDA applicant

Klarity Medical Products, LLC

Newark, OH1 decision2013–20131 recall

FDA records 1 decision for Klarity Medical Products, LLC (Newark, OH) in 2013: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Klarity Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2013high 1 (2020) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Klarity Medical Products, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K132124Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 20131cites it

What has FDA decided for it lately?

  • K132124Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 20131 recall

The one decision as Klarity Medical Products, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K132124Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC…Jul 31, 2020Class II

Other applicant names beginning “Klarity”

FDA records each applicant name separately; these may or may not be the same firm.

Klarity Medical & Equipment (GZ) Co., Ltd. 3