510(k) Report

FDA applicant

Hydro-Med Products, Inc.

Dallas, TX13 decisions1978–19941 recall

FDA records 13 decisions for Hydro-Med Products, Inc. (Dallas, TX) from 1978 to 1994: 13 510(k) clearances. Most are in product codes FEM (Accessories, Photographic, For Endoscope…) and IPM (Cover, Limb). 1 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 and plastic surgery panel, where it files most

How often FDA has decided Hydro-Med Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hydro-Med Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hydro-Med 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?

  • FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1decision
  • IPMCover, Limb1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • KMEBedding, Disposable, Medical1decision
  • KQMCamera, Surgical And Accessories1decision
  • KKXDrape, Surgical, Antimicrobial1decision

Also: MMP (1), ILO (1), IYO (1), LPZ (1), IWQ (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K944198Surgical Microscope DrapeHydro-Med Products, Inc. · 19941cites it

What has FDA decided for it lately?

  • K944198Surgical Microscope DrapeHydro-Med Products, Inc. · 1994
  • K940151Ultrasound Probe DrapeHydro-Med Products, Inc. · 19941 recall
  • K940152Camera Cover with Tear TipHydro-Med Products, Inc. · 1994
  • K934630Universal Video/Laser Arm DrapeHydro-Med Products, Inc. · 1994
  • K923099X-Ray DrapesHydro-Med Products, Inc. · 1992
  • K863872Tamper HamperHydro-Med Products, Inc. · 1987
  • K853281EasytopHydro-Med Products, Inc. · 1985
  • K842304The PathfinderHydro-Med Products, Inc. · 1984

All 13 as Hydro-Med Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K940151Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983…Sep 28, 2000

Other applicant names beginning “Hydro-Med”

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

Hydro-Pulse Research, Inc. 1Hydro Floss, Inc. 1