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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

CountryMakers
Italy3
United States3
China3
Mexico2
France2
United Kingdom1
Cambodia1
Singapore1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cedic S.R.L.PESCHIERA BORROMEO MILAN Lombardy, ItalyManufacturer, Specification developer3May 4, 2017000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer1June 9, 2015010api.fda.gov
AVENT S. de R.L. de C.V.NOGALES Sonora, MexicoSpecification developer1May 4, 2017000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler1October 17, 2014000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomSpecification developer1October 21, 2022000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1July 24, 2015010api.fda.gov
Medwin FranceLes Aires Herault, FranceSpecification developer1February 9, 2016000api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer1February 9, 2016000api.fda.gov
Aena Medical (jiangsu) Co.,ltd.Jiangyin City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Camedical Technology (cambodia) Co., Ltd.Samraong Takeo, CambodiaContract manufacturer0000api.fda.gov
CMT Health Pte. Ltd.Singapore, SingaporeSpecification developer0000api.fda.gov
Cedic Srl Divisione StampaggioMIRANDOLA Modena, ItalyContract manufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Kangjin Medical Instrument Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
KB Medical (group) Inc.Irvine, CA, United StatesSpecification developer0000api.fda.gov
Sibemed SRLCrema Cremona, ItalyContract manufacturer0000api.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.