Kit Pak Irrigation Tray

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K900148 ↗

FDA Product Code

EYN

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

• Kit Pak Urinary Care Supplies

  Class II

  FDA 510(k) K925281 Active Cleared 19 Apr 1993

• Skin Scrub Kit

  Class II

  FDA 510(k) K890570 Active Cleared 5 May 1989

• Kit Pak Suction Catheter Kit

  Class I

  FDA 510(k) K885131 Active Cleared 9 Jan 1989

• Kit Pak's Flushing Kit

  Class II

  FDA 510(k) K922051 Active Cleared 17 Jun 1993

• Urinary Drainage Bag

  Class I

  FDA 510(k) K934080 Active Cleared 18 May 1994

• Kit Pak Wet Saline Dressing

  Unclassified

  FDA 510(k) K942959 Active Cleared 14 Feb 1995

See all devices from Kit Pak, Inc. →

• What is the primary clinical use for the Kit Pak Irrigation Tray?

  This tray is specifically designed to facilitate irrigation and aspiration procedures. It is intended for use by clinicians working within the gastroenterology and urology medical specialties.

• Is the Kit Pak Irrigation Tray provided in a sterile state?

  Yes, the device is supplied as a sterile irrigation tray. This ensures that the equipment is ready for use in clinical environments where maintaining a sterile field is required for patient safety during procedures.

• What is the regulatory status of this irrigation tray?

  The Kit Pak Irrigation Tray is classified as a Class 2 medical device under regulation number 876.5980. It has received FDA 510(k) clearance, recorded under submission number K900148.