Secura IV Volumetric Infusion Pump
by Diatek, Inc. 510(k)
Active
510(k) K830355
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830355 | Date1 Mar 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Secura IV Volumetric Infusion Pump is a Class II infusion pump designed for precise fluid delivery in medical settings. It operates as a volumetric pump to administer controlled amounts of fluids to patients.
This device is used in general hospital settings and is supplied by Diatek, Inc. It received FDA 510(k) clearance with K number K830355 on March 1, 1983, and is classified under product code FRN. The pump is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Other devices from Diatek, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Secura IV Volumetric Infusion Pump used for?
The Secura IV Volumetric Infusion Pump is designed for precise fluid delivery in medical settings, specifically for administering controlled amounts of fluids to patients in general hospital environments.
Is the Secura IV pump single-use or reusable?
The device data does not specify whether the Secura IV Volumetric Infusion Pump is single-use or reusable. No information regarding sterility or MRI safety is provided in the available specifications.
What regulatory approvals does the Secura IV pump have?
The Secura IV Volumetric Infusion Pump received FDA 510(k) clearance with K number K830355 on March 1, 1983. It is classified as a Class II device under product code FRN and is considered substantially equivalent to other devices in its category.
What are the storage requirements for the Secura IV pump?
No specific storage conditions are provided in the device data. The information available does not include details about storage requirements, temperature ranges, or environmental considerations for the Secura IV Volumetric Infusion Pump.