Model H12-10 Dialyzer
by Hospal Medical Corp. 510(k)
Active
510(k) K812575
Overview
The Model H12-10 is a high-permeability dialyzer designed for hemodialysis. It facilitates the removal of waste products and excess fluids from the blood by diffusion and convection, supporting renal replacement therapy in patients with acute or chronic kidney failure. Its high-permeability membrane enables efficient clearance of middle molecules and solutes, improving treatment outcomes for conditions requiring dialysis.
This single-use, sterile device is intended for use in clinical settings such as hospitals and dialysis centers. Supplied as a sealed, ready-to-use unit, it requires no additional preparation beyond connection to a dialysis circuit. The Model H12-10 is classified as a Class II medical device under FDA regulations (21 CFR 876.5860) and holds a Traditional 510(k) clearance (K812575) for substantial equivalence. It is not MRI-compatible and must be handled according to standard sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812575 | Date19 Oct 1981 | 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- Withdrawn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
- Full name
- Model H12-10
- 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
Other devices from Hospal Medical Corp.
Questions
What is the primary purpose of the Model H12-10 dialyzer?
The Model H12-10 is designed specifically for hemodialysis to remove waste products and excess fluids from the blood through processes called diffusion and convection. Its high-permeability membrane enhances the clearance of middle molecules and solutes, making it particularly effective for patients with acute or chronic kidney failure requiring renal replacement therapy.
Is the H12-10 dialyzer single-use or reusable?
The Model H12-10 is a single-use device. It is supplied as a sterile, sealed unit, meaning it is intended for one-time use only and requires no additional preparation beyond connecting it to a dialysis circuit. This design ensures patient safety and reduces the risk of contamination.
How should the H12-10 dialyzer be stored before use?
The H12-10 dialyzer should be stored according to standard sterile medical device protocols. Since it is pre-sterilized and sealed, it should remain in its original packaging until immediately before use. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these conditions could compromise sterility or integrity.
Can the H12-10 dialyzer be used in an MRI environment?
No, the Model H12-10 is explicitly stated as not MRI-compatible. This means it should not be used in or near MRI machines, as the magnetic fields could potentially damage the device or pose risks to the patient.
What regulatory approvals does the H12-10 dialyzer hold?
The Model H12-10 holds a Traditional 510(k) clearance (K812575) from the FDA, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5860). These approvals ensure it meets established safety and performance standards for use in hemodialysis.