Product code KDK— Gastroenterology, Urology
HYPOTRANS MODEL 750
- Classification name
- Container, Transport, Kidney
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code KDK
FDA has cleared devices under product code KDK between 1980 and 2006, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2006
- 1992
- 1980
Top applicants under product code KDK
Recent clearances under product code KDK
Data sourced from openFDA. This site is unofficial and independent of the FDA.