DeviceClearance

Product code KFM— Cardiovascular

CAPIOX SP PUMP HEAD

Classification name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class
Class 2
Regulation
21 CFR 870.4360
Advisory panel
Cardiovascular
Total cleared
84
First cleared
Most recent

Market context for product code KFM

FDA has cleared 84 devices under product code KFM between 1977 and 2025, filed by 41 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

last 15 years

Top applicants under product code KFM

Adverse events under product code KFM

product code KFM
Death
109
Injury
241
Malfunction
1,779
Total
2,129

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 KFM

Data sourced from openFDA. This site is unofficial and independent of the FDA.