Non-Coring (Huber) Needle
FDA product code PTI · Class II (moderate risk) · 21 CFR 880.5570 · General Hospital
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.
13510(k) clearances
0PMA approvals
12recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPTI · Traditional | Sb-Kawasumi Laboratories, Inc. | 11/26/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 03/14/2025SE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle SetPTI · Traditional | Bard Access Systems, Inc. | 11/27/2024SE |
| K230715 | Promisemed Safety Huber NeedlePTI · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/08/2023SE |
| K213823 | Intera Refill KitPTI · Special | Intera Oncology, Inc. | 03/16/2022SE |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…PTI · Traditional | Intera Oncology, Inc. | 10/14/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | Jiangsu Caina Medical Co.,Ltd | 04/07/2021SE |
| K170881 | ISP Safety Huber Needle Infusion SetPTI · Traditional | Infusion Safety Products, Inc. | 12/14/2017SE |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…PTI · Traditional | B.Braun Medical, Inc. | 11/03/2017SE |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI · Special | C.R. Bard, Inc. | 08/08/2017SE |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion SetPTI · Special | Medcomp (Dba Medical Components, Inc.) | 07/18/2017SE |
| K162271 | Pro-Lock CT Safety Infusion SetPTI · Traditional | Medcomp (Medical Components, Inc.) | 04/26/2017SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2671-2020 Class II | SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2670-2020 Class II | PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2669-2020 Class II | SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2668-2020 Class II | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2667-2020 Class II | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2666-2020 Class II | SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482)…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2665-2020 Class II | SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2664-2020 Class II | SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2663-2020 Class II | PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2662-2020 Class II | PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2661-2020 Class II | PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |
| Z-2660-2020 Class II | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | Becton Dickinson & Company | 06/19/2020Terminated |