Panels › General Hospital › Product code PTI · Class 2
Non-Coring (Huber) Needle
Regulation 880.5570
2510(k)s in 12 months (14 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in PTI
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton Dickinson & Company | 0 | 12 |
| Promisemed Hangzhou Meditech Co., Ltd. | 3 | 0 |
| Intera Oncology, Inc. | 2 | 0 |
| B.Braun Medical, Inc. | 1 | 0 |
| Bard Access Systems, Inc. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Infusion Safety Products, Inc. | 1 | 0 |
| Jiangsu Caina Medical Co.,Ltd | 1 | 0 |
| Martech Medical Products | 1 | 0 |
| Medcomp (Dba Medical Components, Inc.) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K254095 | 25G Huber Needle Martech Medical Products | PTI |
| Nov 26, 2025 | K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing Sb-Kawasumi Laboratories, Inc., JP | PTI |
| May 13, 2025 | K251138 | Promisemed Safety Huber Needles Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Mar 14, 2025 | K243332 | Promisemed Safety Huber Needles Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Nov 27, 2024 | K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set Bard Access Systems, Inc. | PTI |
| Jun 8, 2023 | K230715 | Promisemed Safety Huber Needle Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Mar 16, 2022 | K213823 | Intera Refill Kit Intera Oncology, Inc. | PTI |
| Oct 14, 2021 | K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit Intera Oncology, Inc. | PTI |
| Apr 7, 2021 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set Jiangsu Caina Medical Co.,Ltd, CN | PTI |
| Dec 14, 2017 | K170881 | ISP Safety Huber Needle Infusion Set Infusion Safety Products, Inc. | PTI |
| Nov 3, 2017 | 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. | PTI |
| Aug 8, 2017 | K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set C.R. Bard, Inc. | PTI |
| Jul 18, 2017 | K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set Medcomp (Dba Medical Components, Inc.) | PTI |
| Apr 26, 2017 | K162271 | Pro-Lock CT Safety Infusion Set Medcomp (Medical Components, Inc.) | PTI |
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