510(k) Report

FDA applicant

Urit Medical Electronic Co., Ltd.

Great Neck, NY2 decisions2009–20240 recalls

FDA records 2 decisions for Urit Medical Electronic Co., Ltd. (Great Neck, NY) from 2009 to 2024: 2 510(k) clearances. All are in product code JIO (Blood, Occult, Colorimetric, In Urine). Its devices cite 6 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, hematology panel, where it files most

How often FDA has decided Urit Medical Electronic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12024: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Urit Medical Electronic Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JIOBlood, Occult, Colorimetric, In Urine2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 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.

  • K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd. · 2024
  • K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009

All 2 as Urit Medical Electronic Co., Ltd. →