Acute Hemodialysis Trays

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K844612 ↗

FDA Product Code

KNZ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Tracheostomy Care Trays

  Class II

  FDA 510(k) K832880 Active Cleared 31 Oct 1983

• Bone Marrow Tray

  Class I

  FDA 510(k) K863326 Active Cleared 16 Sep 1986

• Central Vein Catherization Tray Cc-20

  Class II

  FDA 510(k) K834073 Active Cleared 28 Feb 1984

• P.T.I. Dressing Change Trays

  Class I

  FDA 510(k) K833758 Active Cleared 26 Jan 1984

• Renal Biopsy Tray

  Class II

  FDA 510(k) K850438 Active Cleared 26 Feb 1985

• Shave Prep Tray

  Class I

  FDA 510(k) K850544 Active Cleared 12 Mar 1985

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