510(k) Report

FDA applicant

L H M Ent., Inc.

Palm Harbor, FL6 decisions1988–19900 recalls

FDA records 6 decisions for L H M Ent., Inc. (Palm Harbor, FL) from 1988 to 1990: 6 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and FIH (Pump, Infusion Or Syringe, Extra-Luminal). 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, anesthesiology panel, where it files most

How often FDA has decided L H M Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for L H M Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — L H M Ent., 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?

  • BTOTube, Tracheostomy (W/Wo Connector)2decisions
  • FIHPump, Infusion Or Syringe, Extra-Luminal1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • KYZSyringe, Irrigating (Non Dental)1decision
  • FSMTray, Surgical, Instrument1decision

What has FDA decided for it lately?

  • K901079Single-Use, Sterile 4OZ Bottle Contain Ster. WaterL H M Ent., Inc. · 1990
  • K901078Single-Use, Sterile 4OZ Bottle Contain 0.9% SalineL H M Ent., Inc. · 1990
  • K894610Custom Trays, KitsL H M Ent., Inc. · 1990
  • K900439Single-Use, Sterile, Prefilled Syringe, 60CCL H M Ent., Inc. · 1990
  • K894611Catheter Care KitsL H M Ent., Inc. · 1989
  • K883506Irrigation KitL H M Ent., Inc. · 1988

All 6 as L H M Ent., Inc. →