Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K162271Substantially Equivalent

Pro-Lock CT Safety Infusion Set

Medcomp ( Medical Components), Harleysville PA / Traditional, Substantially Equivalent

K162271 is the FDA 510(k) clearance record for Pro-Lock CT Safety Infusion Set, a class II device, cleared for Medcomp (Medical Components, Inc.) on under FDA product code PTI (Non-Coring (Huber) Needle). FDA's definition for product code PTI reads: "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". FDA records list 13 510(k) clearances for Medcomp (Medical Components, Inc.), from to . As of , FDA records show no recalls naming K162271.

Clearance record

Decision date
Received
(257 days to decision)
Product code
PTI Non-Coring (Huber) Needle
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Medcomp (Medical Components, Inc.) 1499 Delp Dr., Harleysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTI

Trailing 12 months
2 clearances under product code PTI in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PTI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260