Pack H Hemodialysis Urea Kinetic Modeling Software Program
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K955423 FDA 510(k)
- FDA Product Code
- FKP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pack H Hemodialysis Urea Kinetic Modeling Software Program is a System, Dialysate Delivery, Single Patient software tool designed for urea kinetic modeling. It calculates and optimizes hemodialysis treatment parameters to enhance the removal of urea and other waste products from a patient’s bloodstream, improving treatment efficacy.
This software is supplied as a digital program for use in hemodialysis settings and is intended for single-patient applications. It is classified as a Class II device under FDA regulation 876.5820, with an FDA 510(k) clearance (K955423) granted under the FKP product code. The program is not described as single-use or reusable, nor is MRI safety or sterility specified in the regulatory data.
Frequently asked questions
What is the primary purpose of the Pack H Hemodialysis Urea Kinetic Modeling Software Program and how does it improve treatment for patients?
The Pack H Hemodialysis Urea Kinetic Modeling Software Program is designed to calculate and optimize hemodialysis treatment parameters specifically for urea kinetic modeling. By analyzing patient data, it helps enhance the removal of urea and other waste products from the bloodstream during dialysis, thereby improving the overall efficacy and effectiveness of the treatment for individual patients.
Is this software intended for single-patient use only, and if so, how does that affect its application in a clinical setting?
Yes, the Pack H Hemodialysis Urea Kinetic Modeling Software Program is explicitly intended for single-patient applications. This means it is tailored to analyze and optimize dialysis treatment parameters for one patient at a time, ensuring personalized care and accurate modeling of urea removal during hemodialysis sessions.
How is the Pack H Hemodialysis Urea Kinetic Modeling Software Program supplied, and what type of environment is it intended for?
The software is supplied as a digital program, meaning it is not a physical device but rather a computer-based tool. It is designed for use in hemodialysis settings, where it can be integrated into existing systems to assist clinicians in optimizing dialysis treatments for patients.
What regulatory pathway was followed for the FDA clearance of this software, and what does that mean for its use in clinical practice?
The Pack H Hemodialysis Urea Kinetic Modeling Software Program received FDA clearance through a traditional 510(k) process, specifically under the FKP (Fistula, Graft, and Prosthesis) product code category, with a clearance number of K955423. This means the software was evaluated for substantial equivalence to a predicate device and is now legally marketable in the U.S. for its intended single-patient urea kinetic modeling applications in hemodialysis.
Does this software require any specific storage conditions, or is it subject to sterility or reuse limitations?
Since the Pack H Hemodialysis Urea Kinetic Modeling Software Program is a digital program and not a physical medical device, it does not require traditional storage conditions like temperature control or sterility. Additionally, it is not classified as single-use or reusable in the regulatory data, meaning it remains functional for ongoing use in hemodialysis settings as long as it is properly maintained and updated.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pack H Hemodialysis Urea Kinetic Modeling Software Program, PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM 510 (k ..., pack h hemodialysis urea kinetic modeling software program, Pack H Hemodialysis Urea Kinetic Modeling Software Program
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955423 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Usa, Inc.
Sources (1)
- FDA 510(k) K955423 24 fields · synced Sep 19, 2026