# K230715: Promisemed Safety Huber Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jun 8, 2023 after 85 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; 1 cites 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 4.

## Most influential descendants
- K243332: Promisemed Safety Huber Needles (2025), 1 descendant of its own
- K251138: Promisemed Safety Huber Needles (2025), 0 descendants of its own

## Indications for use
The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Source page: https://510kreport.com/device/K230715
Methodology: https://510kreport.com/methodology