FDA applicant

Nipro Diagnostics, Inc.

Fort Lauderdale, FL4 decisions2013–20155 recalls

FDA records 4 decisions for Nipro Diagnostics, Inc. (Fort Lauderdale, FL) from 2013 to 2015: 4 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). 5 recalls are linked to its devices, 3 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Nipro Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013high 2 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2026

2013high 3 (2026) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Nipro Diagnostics, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nipro Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Nipro”

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

Nipro Medical Corporation 62 Nipro Diabetes Systems, Inc. 5 Nipro Renal Solutions USA, Corp. 2 Nipro Company, Ltd. 1 Nipro Technical Solutions, Incoporated 1

Nipro Diagnostics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Nipro”