510(k) Report

FDA applicant

Clinical Systems, Inc.

Great Neck, NY3 decisions1990–19930 recalls

FDA records 3 decisions for Clinical Systems, Inc. (Great Neck, NY) from 1990 to 1993: 3 510(k) clearances. Most are in product codes LZH (Pump, Infusion, Enteral) and FRN (Pump, Infusion). 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, general hospital panel, where it files most

How often FDA has decided Clinical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LZHPump, Infusion, Enteral1decision
  • FRNPump, Infusion1decision
  • FNMMattress, Air Flotation, Alternating Pressure1decision

What has FDA decided for it lately?

  • K921050Ultraflo Ratesaver Plus Infusion PumpClinical Systems, Inc. · 1993
  • K915061Proact Cla-1500 SystemClinical Systems, Inc. · 1992
  • K901458Nutricare Enfutec 1000 Enteral Feeding PumpClinical Systems, Inc. · 1990

All 3 as Clinical Systems, Inc. →