Product code KZL— Hematology
CIRCULATING CYTO-THERMS
- Classification name
- Device, Warming. Blood And Plasma
- Device class
- Class 2
- Regulation
- 21 CFR 864.9205
- Advisory panel
- Hematology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code KZL
FDA has cleared devices under product code KZL between 1979 and 1982, 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
- 1982
- 1981
- 1980
- 1979
Top applicants under product code KZL
Adverse events under product code KZL
product code KZL- Death
- 3
- Malfunction
- 473
- Total
- 476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KZL
Data sourced from openFDA. This site is unofficial and independent of the FDA.