FDA product code PIO: Enteral Specific Transition Connectors
PIO is the FDA product code for enteral specific transition connectors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under PIO, 3 in the last five years, from 7 different applicants. The average 510(k) review took 188 days (median 225); 188 days on average over the last three years. FDA has posted 3 recalls for PIO devices, 2 initiated in the last five years.
Definition
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Classification
| Field | Value |
|---|---|
| Device name | Enteral Specific Transition 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 PIO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 267 |
| 2022 | 1 | 274 |
| 2024 | 2 | 188 |
Compare with all 510(k) review times · Search every PIO clearance
Top PIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cedic S.R.L. | 3 | 2017-05-04 |
| Cair Lgl | 1 | 2024-01-22 |
| Jiangsu Caina Medical Co.,Ltd | 1 | 2024-01-18 |
| GBUK Group, Ltd. | 1 | 2022-10-21 |
| Vygon | 1 | 2016-02-09 |
2 more applicants have PIO clearances. See the full list in Caduvo.
Most recent PIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231299 | Cair Lgl | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | 2024-01-22 | 263 |
| K233190 | Jiangsu Caina Medical Co.,Ltd | ENFit Adaptor | 2024-01-18 | 112 |
| K220165 | GBUK Group, Ltd. | Enteral Transition Adaptor | 2022-10-21 | 274 |
| K162254 | Cedic S.R.L. | Cedic Enteral ENFit Transition Connectors | 2017-05-04 | 267 |
| K151237 | Vygon | Nutrisafe 2- ENFit Adaptor | 2016-02-09 | 274 |
Recalls for PIO devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-02-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code PIO?
PIO is the FDA product code for enteral specific transition 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 PIO?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIO?
Across 9 cleared submissions the average was 188 days from receipt to decision (median 225).
Which companies have the most PIO clearances?
Cedic S.R.L. (3); Cair Lgl (1); Jiangsu Caina Medical Co.,Ltd (1); GBUK Group, Ltd. (1); Vygon (1).
Have PIO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2026-02-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PIO
- Run a recall and safety report across every PIO manufacturer
- Watch product code PIO 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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