DeviceClearance

Product code PTI— General Hospital

Promisemed Safety Huber Needles

Classification name
Non-Coring (Huber) Needle
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Total cleared
13
First cleared
Most recent

FDA classification definition

“The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.”

— U.S. Food and Drug Administration, device classification record for product code PTI under 21 CFR 880.5570, via openFDA

Market context for product code PTI

FDA has cleared 13 devices under product code PTI between 2017 and 2025, filed by 10 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 PTI

Recent clearances under product code PTI

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