H1207
by Hospal Medical Corp. 510(k)
Active
510(k) K830648
Overview
The H1207 is a high permeability dialyzer used in hemodialysis procedures. It functions to filter blood by removing waste products and excess fluid from the circulatory system.
This device is manufactured by Hospal Medical Corp. and has received FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 876.5860.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830648 | Date29 Mar 1983 | 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- Withdrawn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
- 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 function of the H1207 dialyzer?
The H1207 is a high permeability dialyzer designed for use during hemodialysis procedures. Its function is to filter a patient's blood by removing accumulated waste products and excess fluid from the circulatory system.
What is the regulatory classification of this device?
The H1207 is classified as a Class 2 medical device under regulation number 876.5860. It has received FDA 510(k) clearance, which indicates it has been found substantially equivalent to a legally marketed predicate device.
Who is the manufacturer of the H1207?
The H1207 is manufactured by Hospal Medical Corp., located in McHenry, Illinois.