Medsurg Acute Dialysis Tray

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K880778 ↗

FDA Product Code

LFJ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sterile Scrubby Scrub Brush

  Class I

  FDA 510(k) K875033 Active Cleared 19 Feb 1988

• Medsurg Custom Dressing Trays

  Not classified

  FDA 510(k) K861693 Active Cleared 8 Jul 1986

• Medsurg 7 Fr. Dual Lumen Central Vein Cath System

  Class II

  FDA 510(k) K880771 Active Cleared 3 May 1988

• Medsurg Circumcision Tray

  Class II

  FDA 510(k) K920838 Active Cleared 15 Oct 1993

• Medsurg Single Use Basin Set

  Not classified

  FDA 510(k) K861784 Active Cleared 21 May 1986

• Medsurg Epidural Tray/19 Gage Open End Tuohy 1012

  Class II

  FDA 510(k) K890733 Active Cleared 23 Jun 1989

See all devices from Medsurg Industries, Inc. →

• What clinical settings is the Medsurg Acute Dialysis Tray intended for, and how does that relate to its design?

  The Medsurg Acute Dialysis Tray is designed for use in Gastroenterology and Urology settings, as indicated by its FDA submission. Its purpose is to provide a sterile, organized setup for connecting and managing subclavian catheters during acute dialysis procedures, ensuring proper vascular access for hemodialysis or related interventions. The tray’s design aligns with these specialties by facilitating precise catheter handling in procedures where subclavian access is critical.

• Is the Medsurg Acute Dialysis Tray reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The Medsurg Acute Dialysis Tray is intended for single-use only, as explicitly stated in its description. To maintain sterility, it must be stored and handled according to sterile medical device protocols, ensuring no contamination occurs before use. Single-use design minimizes infection risks and aligns with best practices for acute dialysis setups.

• What does the FDA’s Traditional 510(k) clearance from 1988 mean for this device’s use today, and how does it relate to its classification?

  The Traditional 510(k) clearance (K880778) granted in 1988 confirms the Medsurg Acute Dialysis Tray is classified as a Class II device under FDA’s Catheter, Subclavian (LFJ) product code. This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and performance standards for its intended use in acute dialysis procedures. While cleared decades ago, the device remains compliant with FDA requirements for its classification.

• Are there multiple sizes or models of the Medsurg Acute Dialysis Tray, and how can I identify the correct one for my procedure?

  The provided data lists multiple FEI numbers (e.g., 1000138054, 3007544634), which typically correspond to different size or configuration variants of the tray. While exact dimensions or model distinctions aren’t detailed here, these identifiers suggest the tray may offer flexibility to accommodate various subclavian catheter setups. For precise sizing, consult the manufacturer’s documentation or contact Medsurg Industries, Inc. (Herndon, VA) for guidance tailored to your procedural needs.

• Does the Medsurg Acute Dialysis Tray have any special storage requirements beyond standard sterile packaging?

  Beyond adhering to sterile medical device protocols, the tray’s storage should follow general guidelines for single-use sterile trays: protect from moisture, physical damage, and extreme temperatures. Since it’s supplied sterile, ensure the packaging remains intact until use. No additional MRI compatibility or environmental constraints are noted, so standard clinical storage practices should suffice.