# K171333: 20G x 5/8 Pro-Lock CT Safety Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Medcomp (Dba Medical Components, Inc.)
- Decided: Jul 18, 2017 after 71 days
- Product code: PTI (Non-Coring (Huber) Needle)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162271: Pro-Lock CT Safety Infusion Set, Medcomp (Medical Components, Inc.) (2017) Summary page 4.

## Indications for use
The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

Source page: https://510kreport.com/device/K171333
Methodology: https://510kreport.com/methodology