DeviceClearance

Product code FRN— General Hospital

INFUSION PUMP

Classification name
Pump, Infusion
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
849
First cleared
Most recent

Market context for product code FRN

FDA has cleared 849 devices under product code FRN between 1976 and 2026, filed by 269 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 FRN

Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

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 FRN

1–100 of 849

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