510(k) K251138
- Device
- Promisemed Safety Huber Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- 510(k) number
- K251138
- Product code
- PTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-13
- Date received
- 2025-04-14
- Regulation
- 880.5570
- Classification name
- Non-Coring (Huber) Needle
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Zearou Yang
- Address
- # 1388 Cangxing St., Cangqian Community,Yuhang District Hangzhou City CN 311121 311121
FDA Registration Numbers
- 3038356900
- 1221765
- 3017509841
- 2245539
- 9615908
- 3030733800
- 3010220595
- 1221541
- 1000163068
- 2246552
- 3010055973
- 3010515547
- 9612452
- 3013764800
- 9617592
- 3015142721
- 3010421104
- 3006260740
- 2030624
- 3006082230
- 1018233
- 1055927
- 3013557562
- 3005670221
- 9612086
- 2518902
- 3007829657
- 3003915875
- 3015537318
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344039890 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039883 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039876 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039869 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039852 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039845 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039838 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039784 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039746 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039906 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-09-27 |
Other 510(k) Records For Product Code PTI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | 2024-11-27 |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | 2022-03-16 |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. | 2021-10-14 |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021-04-07 |
| K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | 2017-12-14 |
| 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. | 2017-11-03 |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | 2017-08-08 |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017-07-18 |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017-04-26 |