510(k) Report

FDA applicant

Prime Medical Products, Inc.

Windermere, FL2 decisions1992–19930 recalls

FDA records 2 decisions for Prime Medical Products, Inc. (Windermere, FL) from 1992 to 1993: 2 510(k) clearances. Most are in product codes MEA (Pump, Infusion, Pca) and MEB (Pump, Infusion, Elastomeric). 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 Prime Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prime Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prime Medical Products, 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?

  • MEAPump, Infusion, Pca1decision
  • MEBPump, Infusion, Elastomeric1decision

What has FDA decided for it lately?

  • K920637Prime Pca and Pca/Continuous SystemsPrime Medical Products, Inc. · 1993
  • K914148Prime Cadi-120Prime Medical Products, Inc. · 1992

All 2 as Prime Medical Products, Inc. →

Other applicant names beginning “Prime”

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

Prime Dental Manufacturing, Inc. 9Prime Herbs Corporation 2Prime Pacific Health Innovations Corporation 2Prime Horizon, Inc. 1Prime Ideas, Inc. 1Prime Merit Intl. Corp. 1Prime Engineering 1