Enteral Transition Adaptor
FDA 510(k) K220165 · GBUK Group, Ltd.
510(k) numberK220165
Submission
- Device name
- Enteral Transition Adaptor
- Applicant
- GBUK Group, Ltd.
Selby, GB - Received
- January 20, 2022
- Decision date
- October 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PIO – Enteral Specific Transition Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Other 510(k)s with product code PIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connectorPIO · Traditional | Cair Lgl | 01/22/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | Jiangsu Caina Medical Co.,Ltd | 01/18/2024SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | Cedic S.R.L. | 05/04/2017SE |
| K151237 | Nutrisafe 2- ENFit AdaptorPIO · Traditional | Vygon | 02/09/2016SE |
| K151628 | Medline ENFit ConnectorsPIO · Traditional | Medline Industries, Inc. | 07/24/2015SE |
| K150034 | AMT Enteral Transition AdaptersPIO · Traditional | Applied Medical Technology, Inc. | 06/09/2015SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | Cedic S.R.L. | 04/02/2015SE |
| K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…PIO · Traditional | Cedic S.R.L. | 10/17/2014SE |
More from Cedic S.R.L.
| 510(k) | Device | Decision |
|---|---|---|
| K203633 | Enteral Extension SetsPIF · Traditional | 08/19/2021SE |
Questions and answers
When was Enteral Transition Adaptor cleared by the FDA?
Enteral Transition Adaptor (K220165) received a 510(k) decision of Substantially Equivalent on October 21, 2022, 274 days after the submission was received.
What is the product code of K220165?
The FDA product code is PIO – Enteral Specific Transition Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.