FDA product code PND: Midline Catheter
PND is the FDA product code for midline catheter. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 13 510(k) submissions under PND, 3 in the last five years, from 9 different applicants. The average 510(k) review took 160 days (median 159); 140 days on average over the last three years. FDA has posted 10 recalls for PND devices, 5 initiated in the last five years.
Definition
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Classification
| Field | Value |
|---|---|
| Device name | Midline Catheter |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PND
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 158 |
| 2018 | 2 | 169 |
| 2019 | 1 | 28 |
| 2021 | 1 | 231 |
| 2022 | 2 | 246 |
| 2025 | 1 | 140 |
Compare with all 510(k) review times · Search every PND clearance
Top PND applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 4 | 2022-05-13 |
| Pfm Medical, Inc. | 2 | 2019-10-28 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | 1 | 2025-12-18 |
| Arrow International, LLC Subsidiary of Teleflex Incorporated | 1 | 2022-09-02 |
| Piper Access, LLC | 1 | 2021-08-27 |
4 more applicants have PND clearances. See the full list in Caduvo.
Most recent PND clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252402 | Terumo Medical Products (Hangzhou) Co., Ltd. | Midline Catheter | 2025-12-18 | 140 |
| K213855 | Arrow International, LLC Subsidiary of Teleflex Incorporated | Arrow Pressure Injectable Midline Catheter | 2022-09-02 | 266 |
| K213203 | C.R. Bard, Inc. | Provena(TM) Midline Catheter | 2022-05-13 | 226 |
| K210047 | Piper Access, LLC | Stiletto Extended Dwell Catheter | 2021-08-27 | 231 |
| K192802 | Pfm Medical, Inc. | primeMidline Catheters | 2019-10-28 | 28 |
Recalls for PND devices
10 product recalls in 7 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 3 |
| 2022 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code PND?
PND is the FDA product code for midline catheter. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is PND?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code PND?
Across 13 cleared submissions the average was 160 days from receipt to decision (median 159).
Which companies have the most PND clearances?
C.R. Bard, Inc. (4); Pfm Medical, Inc. (2); Terumo Medical Products (Hangzhou) Co., Ltd. (1); Arrow International, LLC Subsidiary of Teleflex Incorporated (1); Piper Access, LLC (1).
Have PND devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code PND
- Run a recall and safety report across every PND manufacturer
- Watch product code PND 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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