FDA product code PIF: Gastrointestinal Tubes With Enteral Specific Connectors
PIF is the FDA product code for gastrointestinal tubes with enteral specific connectors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 52 510(k) submissions under PIF, 15 in the last five years, from 36 different applicants. The average 510(k) review took 172 days (median 162); 183 days on average over the last three years. FDA has posted 112 recalls for PIF devices, 5 initiated in the last five years.
Definition
To facilitate enteral specific connections.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PIF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 195 |
| 2018 | 2 | 136 |
| 2019 | 7 | 153 |
| 2020 | 4 | 164 |
| 2021 | 4 | 219 |
| 2022 | 4 | 159 |
| 2023 | 4 | 227 |
| 2024 | 2 | 188 |
| 2025 | 2 | 162 |
| 2026 | 3 | 200 |
Compare with all 510(k) review times · Search every PIF clearance
Top PIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medline Industries, Inc. | 3 | 2019-12-04 |
| Covidien | 3 | 2015-10-08 |
| Maquet Critical Care AB | 2 | 2026-08-26 |
| Degania Silicone , Ltd. | 2 | 2026-03-20 |
| Rockfield Medical | 2 | 2024-04-12 |
31 more applicants have PIF clearances. See the full list in Caduvo.
Most recent PIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260110 | Danumed Medizintechnik GmbH | danumed Extension Set for Gastrostomy Button | 2026-09-10 | 239 |
| K253715 | Maquet Critical Care AB | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | 2026-08-26 | 275 |
| K254170 | Degania Silicone , Ltd. | Percutaneous Endoscopic Gastrostomy (PEG) Kit | 2026-03-20 | 87 |
| K242917 | HMC Premedical S.p.A. | Enteral Drainage System, Enteral Medicine straw | 2025-06-18 | 267 |
| K250481 | SKY Medical, a.s. | Extension Feeding Set with ENFit Connectors | 2025-04-18 | 58 |
Recalls for PIF devices
112 product recalls in 7 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2026-02-10.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code PIF?
PIF is the FDA product code for gastrointestinal tubes with enteral specific connectors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PIF?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIF?
Across 52 cleared submissions the average was 172 days from receipt to decision (median 162).
Which companies have the most PIF clearances?
Medline Industries, Inc. (3); Covidien (3); Maquet Critical Care AB (2); Degania Silicone , Ltd. (2); Rockfield Medical (2).
Have PIF devices been recalled?
Yes: 112 product recalls across 7 recall events; the most recent began 2026-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code PIF
- Run a recall and safety report across every PIF manufacturer
- Watch product code PIF 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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