FDA applicant

Nipro Renal Solutions USA, Corp.

Lewisberry, PA2 decisions2020–20231 recall

FDA records 2 decisions for Nipro Renal Solutions USA, Corp. (Lewisberry, PA) from 2020 to 2023: 2 510(k) clearances. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 7 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, gastroenterology and urology panel, where it files most

How often FDA has decided Nipro Renal Solutions USA, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2026

2020high 1 (2026) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Nipro Renal Solutions USA, Corp. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nipro Renal Solutions USA, Corp.’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 Diabetes Systems, Inc. 5 Nipro Diagnostics, Inc. 4 Nipro Company, Ltd. 1 Nipro Technical Solutions, Incoporated 1

Nipro Renal Solutions USA, Corp.

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”