FDA product code PNG: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
PNG is the FDA product code for peritoneal, drainage catheter for refractory ascites, long-term indwelling. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 15 510(k) submissions under PNG, 4 in the last five years, from 8 different applicants. The average 510(k) review took 161 days (median 141); 204 days on average over the last three years. FDA has posted 13 recalls for PNG devices, 13 initiated in the last five years.
Definition
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Classification
| Field | Value |
|---|---|
| Device name | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PNG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 174 |
| 2021 | 1 | 112 |
| 2023 | 2 | 303 |
| 2024 | 1 | 156 |
| 2025 | 1 | 253 |
Compare with all 510(k) review times · Search every PNG clearance
Top PNG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Care Fusion | 4 | 2020-10-21 |
| Pfm Medical, Inc. | 3 | 2025-01-14 |
| Rocket Medical Plc | 2 | 2016-11-14 |
| C.R. Bard, Inc. | 2 | 2011-05-06 |
| Bard Peripheral Vascular, Inc. | 1 | 2024-12-06 |
3 more applicants have PNG clearances. See the full list in Caduvo.
Most recent PNG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241278 | Pfm Medical, Inc. | ASEPT® Glide Peritoneal Drainage System | 2025-01-14 | 253 |
| K241946 | Bard Peripheral Vascular, Inc. | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | 2024-12-06 | 156 |
| K230319 | Bearpac Medical | Passio Pump Drainage System | 2023-11-24 | 291 |
| K221779 | Pfm Medical, Inc. | ASEPT Peritoneal Drainage System | 2023-05-02 | 315 |
| K212675 | Merit Medical Systems, Inc. | Aspira Peritoneal Drainage System | 2021-12-14 | 112 |
Recalls for PNG devices
13 product recalls in 1 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2023-04-22.
| Year | Recalls |
|---|---|
| 2023 | 13 |
Frequently asked questions
What is FDA product code PNG?
PNG is the FDA product code for peritoneal, drainage catheter for refractory ascites, long-term indwelling. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is PNG?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNG?
Across 15 cleared submissions the average was 161 days from receipt to decision (median 141).
Which companies have the most PNG clearances?
Care Fusion (4); Pfm Medical, Inc. (3); Rocket Medical Plc (2); C.R. Bard, Inc. (2); Bard Peripheral Vascular, Inc. (1).
Have PNG devices been recalled?
Yes: 13 product recalls across 1 recall events; the most recent began 2023-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PNG
- Run a recall and safety report across every PNG manufacturer
- Watch product code PNG 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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