Med-Rx Extension Set With T-Connector
by Benlan, Inc.
510(k) K112799
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112799 | Date23 Dec 2011 | 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- Withdrawn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, 24 Sep 2026
The Med-Rx Extension Set With T-Connector is a medical device used for administration or withdrawal of fluids to or from a patient. It is classified as a Set, Administration, Intravascular device with product code FPA.
The device is supplied as a single unit and is intended for use in a general hospital setting. It is a Class 2 device and has been cleared through the Traditional 510(k) pathway with FDA 510(k) clearance number K112799. The device is manufactured by Benlan, Inc. and has a product code of FPA.
Other devices from Benlan, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Med-Rx Extension Set With T-Connector used for?
The Med-Rx Extension Set With T-Connector is used for administration or withdrawal of fluids to or from a patient in a general hospital setting.
Is the Med-Rx Extension Set With T-Connector supplied sterile?
The description does not explicitly state that the device is supplied sterile, so this information is not available.
What is the regulatory clearance status of the Med-Rx Extension Set With T-Connector?
The device has been cleared through the Traditional 510(k) pathway with FDA 510(k) clearance number K112799.