Huber Needle Infusion Set, Safety Huber Needle Infusion Set
FDA 510(k) K200463 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK200463
Submission
- Device name
- Huber Needle Infusion Set, Safety Huber Needle Infusion Set
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- February 25, 2020
- Decision date
- April 7, 2021
- 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 |
| 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 |
| 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 |
|---|---|---|
| K232781 | Safety Sliding Blood Collection SetJKA · Traditional | 03/07/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | 01/18/2024SE |
| K230635 | Pen NeedleFMI · Traditional | 06/02/2023SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | 07/21/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | 09/30/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | 05/17/2021SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…JKA · Traditional | 09/09/2020SE |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | 07/20/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | 07/17/2020SE |
Questions and answers
When was Huber Needle Infusion Set, Safety Huber Needle Infusion Set cleared by the FDA?
Huber Needle Infusion Set, Safety Huber Needle Infusion Set (K200463) received a 510(k) decision of Substantially Equivalent on April 7, 2021, 407 days after the submission was received.
What is the product code of K200463?
The FDA product code is PTI – Non-Coring (Huber) Needle, a Class II (moderate risk) device regulated under 21 CFR 880.5570.