PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
FDA 510(k) K241353 · Bard Access Systems, Inc.
510(k) numberK241353
Submission
- Device name
- PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- Applicant
- Bard Access Systems, Inc.
Salt Lake Ciy,, UT, US - Received
- May 13, 2024
- Decision date
- November 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PTI – Non-Coring (Huber) Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- 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.
Other 510(k)s with product code PTI
| 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 |
| 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 |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | 06/18/2025SE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | 10/31/2024SE |
| K240146 | BD Prevue II Peripheral Vascular Access SystemIYO · Special | 02/18/2024SE |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC · Special | 11/10/2022SE |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS · Special | 08/24/2022SE |
| K210264 | BD PowerPiCC CatheterLJS · Traditional | 07/30/2021SE |
| K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideIYO · Traditional | 05/30/2012SE |
| K100402 | Site-Rite Vision Ultrasound SystemIYN · Traditional | 03/05/2010SE |
| K071095 | Aspira Pleural Drainage SystemDWM · Traditional | 05/18/2007SE |
Questions and answers
When was PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set cleared by the FDA?
PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set (K241353) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 198 days after the submission was received.
What is the product code of K241353?
The FDA product code is PTI – Non-Coring (Huber) Needle, a Class II (moderate risk) device regulated under 21 CFR 880.5570.