DeviceClearance

Product code PND— General Hospital

PowerMidline Catheter

Classification name
Midline Catheter
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Total cleared
13
First cleared
Most recent

FDA classification definition

“The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.”

— U.S. Food and Drug Administration, device classification record for product code PND under 21 CFR 880.5200, via openFDA

Market context for product code PND

FDA has cleared 13 devices under product code PND between 2016 and 2025, filed by 9 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

Top applicants under product code PND

Adverse events under product code PND

product code PND
Injury
149
Malfunction
695
Other
1
Total
845

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 PND

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