Data / Medical devices / Enteral Specific Transition Connectors
Enteral Specific Transition Connectors (PIO): 16 FDA-registered makers in 8 countries
16 establishments in 8 countries are registered with the FDA to make Enteral Specific Transition Connectors (product code PIO, Class 2, 21 CFR 876.5980). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on January 22, 2024, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PIO
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Italy | 3 |
| United States | 3 |
| China | 3 |
| Mexico | 2 |
| France | 2 |
| United Kingdom | 1 |
| Cambodia | 1 |
| Singapore | 1 |
Makers of Enteral Specific Transition Connectors
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cedic S.R.L. | PESCHIERA BORROMEO MILAN Lombardy, Italy | Manufacturer, Specification developer | 3 | May 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 1 | June 9, 2015 | 0 | 1 | 0 | api.fda.gov |
| AVENT S. de R.L. de C.V. | NOGALES Sonora, Mexico | Specification developer | 1 | May 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 1 | October 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| Gbuk Group Limited | Selby North Yorkshire, United Kingdom | Specification developer | 1 | October 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | July 24, 2015 | 0 | 1 | 0 | api.fda.gov |
| Medwin France | Les Aires Herault, France | Specification developer | 1 | February 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 1 | February 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Aena Medical (jiangsu) Co.,ltd. | Jiangyin City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Camedical Technology (cambodia) Co., Ltd. | Samraong Takeo, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CMT Health Pte. Ltd. | Singapore, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cedic Srl Divisione Stampaggio | MIRANDOLA Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjin Medical Instrument Co.,ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KB Medical (group) Inc. | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sibemed SRL | Crema Cremona, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.