FDA applicant

Nipro Diabetes Systems, Inc.

Lexington, KY5 decisions2001–20071 recall

FDA records 5 decisions for Nipro Diabetes Systems, Inc. (Lexington, KY) from 2001 to 2007: 5 510(k) clearances. Most are in product codes LZG (Pump, Infusion, Insulin) and FMF (Syringe, Piston). Its devices cite 6 predicates, 2 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nipro Diabetes Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nipro Diabetes Systems, Inc.’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

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 Diagnostics, Inc. 4 Nipro Renal Solutions USA, Corp. 2 Nipro Company, Ltd. 1 Nipro Technical Solutions, Incoporated 1

Nipro Diabetes Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

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”