FDA product code PNO: Catheter, Percutaneous, Cutting/Scoring
PNO is the FDA product code for catheter, percutaneous, cutting/scoring. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 45 510(k) submissions under PNO, 9 in the last five years, from 22 different applicants. The average 510(k) review took 103 days (median 61); 155 days on average over the last three years. FDA has posted 3 recalls for PNO devices.
Definition
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PNO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 96 |
| 2019 | 1 | 257 |
| 2020 | 4 | 95 |
| 2021 | 1 | 19 |
| 2022 | 2 | 80 |
| 2024 | 4 | 241 |
| 2025 | 2 | 194 |
| 2026 | 1 | 30 |
Top PNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Angioscore, Inc. | 13 | 2015-03-04 |
| Cagent Vascular, LLC | 5 | 2022-05-04 |
| Bard Peripheral Vascular, Inc. | 2 | 2026-02-04 |
| Goodman Co., Ltd. | 2 | 2025-04-22 |
| Dk Medical Technology Co., Ltd. | 2 | 2025-04-21 |
17 more applicants have PNO clearances. See the full list in Caduvo.
Most recent PNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260012 | Bard Peripheral Vascular, Inc. | UltraScore Focused Force PTA Balloon | 2026-02-04 | 30 |
| K243944 | Goodman Co., Ltd. | Aperta NSE PTA Balloon Dilatation Catheter | 2025-04-22 | 123 |
| K242254 | Dk Medical Technology Co., Ltd. | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | 2025-04-21 | 264 |
| K241478 | Brosmed Medical Co., Ltd. | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | 2024-10-22 | 151 |
| K232258 | Transit Scientific, LLC | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | 2024-06-17 | 322 |
Recalls for PNO devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-24.
| Year | Recalls |
|---|---|
| 2019 | 3 |
Frequently asked questions
What is FDA product code PNO?
PNO is the FDA product code for catheter, percutaneous, cutting/scoring. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is PNO?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNO?
Across 45 cleared submissions the average was 103 days from receipt to decision (median 61).
Which companies have the most PNO clearances?
Angioscore, Inc. (13); Cagent Vascular, LLC (5); Bard Peripheral Vascular, Inc. (2); Goodman Co., Ltd. (2); Dk Medical Technology Co., Ltd. (2).
Have PNO devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2019-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code PNO
- Run a recall and safety report across every PNO manufacturer
- Watch product code PNO 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.