FDA applicant

Nipro Company, Ltd.

Osaka, JP1 decision1985–19850 recalls

FDA records 1 decision for Nipro Company, Ltd. (Osaka, JP) in 1985: 1 510(k) clearance. All are in product code FKP (System, Dialysate Delivery, Single Patient). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Nipro Company, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

Nipro Company, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Nipro”