Dressing Change Tray
510(k) K920339
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SEKD | NumberK920339 | Date23 Apr 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SEKD
Overview
AI-generated summary, 1 Oct 2026
The Dressing Change Tray is a medical device classified under the Dressing Trays category, designed to organize and provide sterile supplies for wound care procedures. It is intended to streamline dressing changes by consolidating essential items such as gauze, adhesive strips, antiseptics, and other wound care materials in a single, accessible tray. This setup enhances efficiency and reduces contamination risks during clinical interventions. The device supports standard wound management protocols in hospital and outpatient settings.
The Dressing Change Tray is supplied in a case of 24 units, ensuring ready availability for healthcare facilities. It is intended for single-use applications, though reusable components may be present depending on institutional protocols. The tray is not labeled as MRI-safe or sterile upon packaging, requiring terminal sterilization or preparation by the user prior to use. Authorized under FDA 510(k) clearance (K920339) and categorized under product code FRG, it adheres to regulatory standards for wound care accessories in clinical environments.
Other devices from Medikmark, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Dressing Change Tray designed to do?
The Dressing Change Tray is engineered to streamline wound care procedures by consolidating essential supplies—such as gauze, adhesive strips, and antiseptics—into a single, organized tray. This reduces clutter, minimizes contamination risks, and improves workflow efficiency during dressing changes in both hospital and outpatient settings.
How is the Dressing Change Tray supplied, and what should users expect?
The tray is supplied in a case containing 24 units, ensuring healthcare facilities have ready access to multiple trays for routine use. However, it is not sterile upon packaging, so users must perform terminal sterilization or prepare it according to their facility’s protocols before clinical application.
Is the Dressing Change Tray intended for single-use or reuse?
The device itself is designed for single-use, though some components within the tray may be reusable depending on institutional protocols. Users should follow their facility’s guidelines for cleaning and reprocessing reusable parts to maintain sterility and compliance with infection control standards.
Does the Dressing Change Tray include any reusable components?
While the primary tray is intended for single-use, certain elements—such as trays or containers—may be designed for reuse if properly cleaned and sterilized. Facilities should establish specific protocols for identifying and reprocessing reusable parts to ensure safety and adherence to clinical best practices.
What regulatory clearance does the Dressing Change Tray hold?
The Dressing Change Tray holds FDA 510(k) clearance under the product code FRG, with the clearance number K920339. This classification confirms its compliance with U.S. regulatory standards for wound care accessories, though users should always verify current status with the manufacturer or regulatory databases.