FDA product code PNE: Reprocessed Catheter Introducer
PNE is the FDA product code for reprocessed catheter introducer. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. FDA has cleared 7 510(k) submissions under PNE, 5 in the last five years, from 4 different applicants. The average 510(k) review took 243 days (median 241); 308 days on average over the last three years.
Definition
Introduce various cardiovascular catheters into the heart and cardiovascular system
Classification
| Field | Value |
|---|---|
| Device name | Reprocessed Catheter Introducer |
| Device class | Class II |
| Regulation | 21 CFR 870.1340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PNE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 121 |
| 2022 | 1 | 241 |
| 2023 | 1 | 175 |
| 2024 | 1 | 269 |
| 2025 | 1 | 318 |
| 2026 | 1 | 338 |
Compare with all 510(k) review times · Search every PNE clearance
Top PNE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 4 | 2024-04-04 |
| Innovative Health | 1 | 2026-01-07 |
| Surgical Instrument Service and Savings, Inc. | 1 | 2025-12-19 |
| Sterilmed, Inc. | 1 | 2016-03-23 |
Most recent PNE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250305 | Innovative Health | Reprocessed Agilis NxT Steerable Introducer | 2026-01-07 | 338 |
| K250314 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | 2025-12-19 | 318 |
| K232037 | Innovative Health, LLC | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | 2024-04-04 | 269 |
| K230376 | Innovative Health, LLC | Reprocessed Agilis NxT Steerable Introducer | 2023-08-07 | 175 |
| K212165 | Innovative Health, LLC | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | 2022-03-10 | 241 |
Recalls for PNE devices
openFDA lists no recalls for product code PNE.
Frequently asked questions
What is FDA product code PNE?
PNE is the FDA product code for reprocessed catheter introducer. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel.
What device class is PNE?
Class II, regulation 21 CFR 870.1340. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNE?
Across 7 cleared submissions the average was 243 days from receipt to decision (median 241).
Which companies have the most PNE clearances?
Innovative Health, LLC (4); Innovative Health (1); Surgical Instrument Service and Savings, Inc. (1); Sterilmed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNE
- Run a recall and safety report across every PNE manufacturer
- Watch product code PNE 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times