510(k) Report

FDA applicant

Renal Scientific Service, Inc.

Waltham, MA1 decision1996–19960 recalls

FDA records 1 decision for Renal Scientific Service, Inc. (Waltham, MA) in 1996: 1 510(k) clearance. All are in product code LIF (Dialyzer Reprocessing System). 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 Scientific Service, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Renal Scientific Service, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Renal Scientific Service, 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.