# K162271: Pro-Lock CT Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp (Medical Components, Inc.)
- Decided: Apr 26, 2017 after 257 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: 10 generations back to K001901 (2000). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132880: Medcomp Power Injectable Safety Huber Needle, Medical Components, Inc. (2014) Summary page 4.

## Most influential descendants
- K171333: 20G x 5/8 Pro-Lock CT Safety Infusion Set (2017), 0 descendants of its own

## 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 sampling 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/K162271
Methodology: https://510kreport.com/methodology