Deka Jr.
by Deka Research & Development Corp. 510(k)
Active
510(k) K863204
Overview
The Deka Jr. is an Infusion Controller, Intravascular, Electronic (Product Code: LDR), classified as a Class II medical device under FDA regulation 880.5725. It is designed to regulate and control the infusion of fluids into the vascular system, ensuring precise delivery for clinical applications in general hospital settings.
This device is supplied as a reusable electronic controller and is intended for use in hospital environments. It was cleared under the FDA’s 510(k) pathway in 1986 (K863204) as substantially equivalent to a predicate device. No additional sterility or MRI safety specifications are noted in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863204 | Date3 Sep 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- LDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Deka Research & Development Corp.
Questions
Is the Deka Jr. designed for single-use or can it be reused in a clinical setting?
The Deka Jr. is explicitly described as a reusable electronic controller in its regulatory submission. Since it is classified as a Class II infusion controller and not a disposable component, it is intended for repeated use within hospital environments, provided it undergoes proper maintenance and cleaning protocols as outlined in the manufacturer’s instructions.
What types of clinical environments is the Deka Jr. intended for, and how does that affect its use?
The Deka Jr. is cleared for use in general hospital settings, as indicated by its advisory committee designation (HO) and regulatory classification under FDA product code LDR (Infusion Controller, Intravascular, Electronic). This means it is designed for controlled fluid delivery in standard inpatient or procedural areas where vascular access is required, such as ICUs, operating rooms, or recovery units.
How is the Deka Jr. supplied, and are there any special handling requirements for storage or preparation before use?
The Deka Jr. is supplied as a reusable electronic device, meaning it is not pre-packaged or sterile out-of-the-box. Since it is not described as sterile in the regulatory data, it must be cleaned and maintained according to the manufacturer’s guidelines before each use. Storage should follow standard protocols for electronic medical equipment to ensure functionality and longevity.
What does the FDA’s 1986 clearance (K863204) mean for the Deka Jr.’s intended use and compatibility with modern medical practices?
The Deka Jr. was cleared under the FDA’s 510(k) pathway in 1986 as substantially equivalent to a predicate device, meaning it met the agency’s requirements at the time for safety and performance in infusion control for general hospital use. While the technology may not incorporate modern advancements like digital connectivity or advanced safety alarms, its core function—regulating fluid infusion—remains valid for compatible clinical applications in settings where legacy infusion systems are still utilized.