Kawasumi I.V. Administration Set with Burette
by Kawasumi Laboratories Co., Ltd.
510(k) K896893
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896893 | Date12 Sep 1990 | 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- Withdrawn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
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Kawasumi I.V. Administration Set with Burette is a set, administration, intravascular device classified under product code FPA. It is designed for the delivery of intravenous fluids and medications, incorporating a burette for precise volume measurement and control during infusion therapy.
This device is supplied as a single-use, sterile product intended for use in general hospital settings. It has received FDA 510(k) clearance (K896893) as substantially equivalent to a predicate device, with traditional clearance granted on September 12, 1990. The device is manufactured by Kawasumi Laboratories Co., Ltd. and is subject to special controls as a Class II medical device.
Other devices from Kawasumi Laboratories Co., Ltd.
Questions
AI-generated answers, 25 Sep 2026
What is the Kawasumi I.V. Administration Set with Burette used for?
The Kawasumi I.V. Administration Set with Burette is designed for the delivery of intravenous fluids and medications, incorporating a burette for precise volume measurement and control during infusion therapy in general hospital settings.
Is this device single-use or reusable?
This device is supplied as a single-use, sterile product and should not be reused to ensure patient safety and maintain sterility.
What regulatory approvals does this device have?
The Kawasumi I.V. Administration Set with Burette has received FDA 510(k) clearance (K896893) as substantially equivalent to a predicate device, with traditional clearance granted on September 12, 1990.
How is the device supplied and what are its storage requirements?
The device is supplied as a sterile product for single-use. While specific storage requirements are not detailed in the provided information, it should be stored according to standard medical device storage practices to maintain sterility until use.