FDA applicant

Renal Solutions, Inc.

Warrendale, PA9 decisions2003–20131 recall

FDA records 9 decisions for Renal Solutions, Inc. (Warrendale, PA) from 2003 to 2013: 9 510(k) clearances. Most are in product codes FKT (System, Dialysate Delivery, Sorbent Regenerated) and KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 12 predicates, 6 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 Renal Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Renal Solutions, 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 “Renal”

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

Renal Systems, Inc. 35 Renal Devices, Inc. 4 Renal Care Corp. 2 Renal Hygienics 1 Renal Scientific Service, Inc. 1 Renal Dynamics, Inc. 1 Renal Care Dialysis Solutions, S.A. DE C.V. 1

Renal Solutions, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Renal”