# K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Apr 7, 2021 after 407 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). 37 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site, B.Braun Medical, Inc. (2017) Summary page 6.

## Most influential descendants
- K254095: 25G Huber Needle (2026), 0 descendants of its own
- K211121: Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit (2021), 0 descendants of its own

## Indications for use
Huber Needle Infusion Set The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. Safety Huber Needle Infusion Set The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Source page: https://510kreport.com/device/K200463
Methodology: https://510kreport.com/methodology