Promisemed Safety Huber Needles
FDA 510(k) K251138 · Promisemed Hangzhou Meditech Co., Ltd.
510(k) numberK251138
Submission
- Device name
- Promisemed Safety Huber Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- April 14, 2025
- Decision date
- May 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | 08/25/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | 05/12/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | 05/01/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | 04/16/2026SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | 06/04/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | 10/04/2024SE |
| K242632 | Verifine® Pen NeedlesFMI · Special | 09/26/2024SE |
Questions and answers
When was Promisemed Safety Huber Needles cleared by the FDA?
Promisemed Safety Huber Needles (K251138) received a 510(k) decision of Substantially Equivalent on May 13, 2025, 29 days after the submission was received.
What is the product code of K251138?
The FDA product code is PTI – Non-Coring (Huber) Needle, a Class II (moderate risk) device regulated under 21 CFR 880.5570.