FDA applicant

Renal Hygienics

Tarzana, CA1 decision1986–19860 recalls

FDA records 1 decision for Renal Hygienics (Tarzana, CA) in 1986: 1 510(k) clearance. All are in product code FKQ (System, Dialysate Delivery, Central Multiple…). 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 Hygienics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Renal Hygienics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Renal Hygienics’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 Scientific Service, Inc. 1 Renal Dynamics, Inc. 1 Renal Care Dialysis Solutions, S.A. DE C.V. 1

Renal Hygienics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Renal”