Deseret Flow Restriction Valve
by Becton Dickinson Vascular Access, Inc.
510(k) K914180
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SEKD | NumberK914180 | Date8 May 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- Withdrawn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
- Full name
- Deseret(R) Flow Restriction Valve
- 510(k) Number
- FDA Product Code
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SEKD
Overview
AI-generated summary, 19 Sep 2026
The Deseret Flow Restriction Valve is a medical device classified as a flow restriction device (product code FOZ) designed to regulate fluid flow in intravenous or infusion systems. It is intended to limit the rate of infusion to prevent rapid administration of fluids, thereby reducing the risk of fluid overload or complications associated with excessive infusion rates.
This valve is supplied as a single-use, non-sterile device and is intended for use in hospital settings. It is not MRI-safe and must be stored in a clean, dry environment until use. The device holds an FDA 510(k) clearance (K914180) under the Traditional pathway, with no third-party involvement. No additional regulatory markings or sterility claims are specified.
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Questions
AI-generated answers, 19 Sep 2026
What is the purpose of the Deseret Flow Restriction Valve?
The Deseret Flow Restriction Valve is designed to regulate fluid flow in intravenous or infusion systems, limiting the rate of infusion to prevent rapid administration of fluids and reduce the risk of fluid overload or complications associated with excessive infusion rates.
Is the Deseret Flow Restriction Valve sterile and reusable?
The Deseret Flow Restriction Valve is supplied as a single-use, non-sterile device, meaning it is intended for one-time use only and does not come in a sterile package.
What are the storage requirements for the Deseret Flow Restriction Valve?
The device must be stored in a clean, dry environment until use, as it is not MRI-safe and requires proper storage conditions to maintain its functionality.
What regulatory pathway was used for the Deseret Flow Restriction Valve?
The device holds an FDA 510(k) clearance (K914180) under the Traditional pathway with no third-party involvement, indicating it was cleared by demonstrating substantial equivalence to a predicate device.