FDA product code PTI: Non-Coring (Huber) Needle
PTI is the FDA product code for non-coring (huber) needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 14 510(k) submissions under PTI, 7 in the last five years, from 11 different applicants. The average 510(k) review took 172 days (median 162); 189 days on average over the last three years. FDA has posted 12 recalls for PTI devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Non-Coring (Huber) Needle |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PTI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 174 |
| 2021 | 2 | 294 |
| 2022 | 1 | 98 |
| 2023 | 1 | 85 |
| 2024 | 1 | 198 |
| 2025 | 3 | 97 |
| 2026 | 1 | 273 |
Compare with all 510(k) review times · Search every PTI clearance
Top PTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | 3 | 2025-05-13 |
| Intera Oncology, Inc. | 2 | 2022-03-16 |
| Martech Medical Products | 1 | 2026-09-18 |
| Sb-Kawasumi Laboratories, Inc. | 1 | 2025-11-26 |
| Bard Access Systems, Inc. | 1 | 2024-11-27 |
6 more applicants have PTI clearances. See the full list in Caduvo.
Most recent PTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254095 | Martech Medical Products | 25G Huber Needle | 2026-09-18 | 273 |
| K252355 | Sb-Kawasumi Laboratories, Inc. | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | 2025-11-26 | 120 |
| K251138 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Safety Huber Needles | 2025-05-13 | 29 |
| K243332 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Safety Huber Needles | 2025-03-14 | 141 |
| K241353 | Bard Access Systems, Inc. | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | 2024-11-27 | 198 |
Recalls for PTI devices
12 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-06-19.
| Year | Recalls |
|---|---|
| 2020 | 12 |
Frequently asked questions
What is FDA product code PTI?
PTI is the FDA product code for non-coring (huber) needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is PTI?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTI?
Across 14 cleared submissions the average was 172 days from receipt to decision (median 162).
Which companies have the most PTI clearances?
Promisemed Hangzhou Meditech Co., Ltd. (3); Intera Oncology, Inc. (2); Martech Medical Products (1); Sb-Kawasumi Laboratories, Inc. (1); Bard Access Systems, Inc. (1).
Have PTI devices been recalled?
Yes: 12 product recalls across 1 recall events; the most recent began 2020-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code PTI
- Run a recall and safety report across every PTI manufacturer
- Watch product code PTI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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