Mixing Container
510(k) K843954
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843954 | Date28 Nov 1984 | 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- Withdrawn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
- KPE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5025
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Mixing Container is an intravenous container designed for the preparation and storage of medical solutions. It functions as a vessel for mixing fluids intended for clinical administration.
This device is regulated under FDA 510(k) clearance K843954. It is categorized under the General Hospital medical specialty and is subject to the requirements for Class 2 medical devices.
Other devices from American Mcgaw
Questions
AI-generated answers, 21 Sep 2026
What is the primary purpose of the Mixing Container?
The Mixing Container is designed to serve as a vessel for the preparation and storage of medical solutions intended for clinical intravenous administration.
How is this device regulated?
This device is regulated under FDA 510(k) clearance K843954. It is classified as a Class 2 medical device within the General Hospital specialty.
Who is the manufacturer of this device?
The Mixing Container is manufactured by American Mcgaw, located in Santa Ana, California.