FDA applicant

Renal Care Dialysis Solutions, S.A. DE C.V.

El Marques, MX1 decision2023–20230 recalls

FDA records 1 decision for Renal Care Dialysis Solutions, S.A. DE C.V. (El Marques, MX) in 2023: 1 510(k) clearance. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Renal Care Dialysis Solutions, S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Renal Care Dialysis Solutions, S.A. DE C.V. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Renal Care Dialysis Solutions, S.A. DE…’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 “Renal”

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

Renal Systems, Inc. 35 Renal Solutions, Inc. 9 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.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Renal”