DeviceClearance

Product code LHI— General Hospital

TRANSFER SET

Classification name
Set, I.V. Fluid Transfer
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Total cleared
207
First cleared
Most recent

Market context for product code LHI

FDA has cleared 207 devices under product code LHI between 1981 and 2026, filed by 106 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 LHI

Adverse events under product code LHI

product code LHI
Injury
207
Malfunction
7,820
Other
3
Total
8,030

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 LHI

1–100 of 207

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