Hemocor HPH Mini Hemoconcentrator
510(k) K980859
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980859 | Date12 May 1998 | 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- Withdrawn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
- KDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hemocor HPH Mini Hemoconcentrator is a high-permeability dialyzer designed for hemoconcentration procedures. It functions by selectively removing plasma water while retaining blood cells, proteins, and other critical components, thereby increasing hematocrit levels in patients. This device is classified as a dialyzer and is intended for use in medical settings where hemoconcentration is required, such as in certain urological or gastrointestinal applications.
The Hemocor HPH Mini Hemoconcentrator is supplied as a single-use device and is regulated under FDA 510(k) clearance (K980859) as substantially equivalent to existing devices. It is intended for use in controlled clinical environments, such as operating rooms or specialized procedure rooms, where precise hemoconcentration is necessary. The device is not MRI-safe and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are mentioned in the specifications.
Other devices from Minntech Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Hemocor HPH Mini Hemoconcentrator used for?
The Hemocor HPH Mini Hemoconcentrator is a high-permeability dialyzer designed specifically for hemoconcentration procedures. It removes plasma water while retaining blood cells, proteins, and other critical components, effectively increasing hematocrit levels in patients. This is particularly useful in medical settings where precise hemoconcentration is required, such as during certain urological or gastrointestinal applications.
Is the Hemocor HPH Mini Hemoconcentrator single-use or reusable?
The Hemocor HPH Mini Hemoconcentrator is supplied as a single-use device. This ensures sterility and safety for each procedure, reducing the risk of contamination or cross-infection between patients. Single-use devices are also designed for convenience and compliance with clinical best practices.
How should the Hemocor HPH Mini Hemoconcentrator be stored to maintain functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping it in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow the storage instructions provided by Minntech Corp. to ensure the device remains effective for its intended use.
Is the Hemocor HPH Mini Hemoconcentrator MRI-safe?
No, the Hemocor HPH Mini Hemoconcentrator is not MRI-safe. This means it should not be used or placed in an MRI environment, as exposure to magnetic fields could compromise the device’s integrity or pose safety risks. Always verify compatibility with imaging equipment before use.
What regulatory approval does the Hemocor HPH Mini Hemoconcentrator hold?
The Hemocor HPH Mini Hemoconcentrator has received FDA 510(k) clearance under the reference number K980859. This clearance indicates that the device is substantially equivalent to legally marketed devices and meets the regulatory requirements for use in the United States. No additional regulatory approvals beyond this are mentioned.